ID

39721

Beschrijving

A Phase 1 Study of PPI-668 in Healthy Volunteers and Patients With Hepatitis C Virus (HCV) Genotype 1; ODM derived from: https://clinicaltrials.gov/show/NCT01448200

Link

https://clinicaltrials.gov/show/NCT01448200

Trefwoorden

Versies (2)
  1. 12-02-20 12-02-20 -
  2. 12-02-20 12-02-20 -
Houder van rechten

See clinicaltrials.gov

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12 februari 2020

DOI

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Licentie

Creative Commons BY 4.0
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Eligibility Hepatitis C, Chronic NCT01448200

Engels

Eligibility Hepatitis C, Chronic NCT01448200

1 Formulieren  
Criteria
Beschrijving

Criteria

key inclusion criteria
Beschrijving

Inclusion criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
1. male or female, between 18 and 65 years of age. female patients must be surgically sterile or two years post-menopausal.
Beschrijving

Age | Female Sterilization | Postmenopausal state Duration

Datatype

boolean

Alias
UMLS CUI [1]
C0001779
UMLS CUI [2]
C0015787
UMLS CUI [3,1]
C0232970
UMLS CUI [3,2]
C0449238
2. body mass index (bmi) 18 - 35 kg/m2
Beschrijving

Body mass index

Datatype

boolean

Alias
UMLS CUI [1]
C1305855
3. in good health, in the judgment of the principal investigator
Beschrijving

Good health

Datatype

boolean

Alias
UMLS CUI [1]
C3813622
4. able and willing to comply with all protocol requirements and to sign an informed consent.
Beschrijving

Protocol Compliance | Informed Consent

Datatype

boolean

Alias
UMLS CUI [1]
C0525058
UMLS CUI [2]
C0021430
key exclusion criteria:
Beschrijving

Exclusion Criteria Main

Datatype

boolean

Alias
UMLS CUI [1,1]
C0680251
UMLS CUI [1,2]
C1542147
1. seropositive for hiv antibody, or hbv surface antigen (hbsag) at screen. volunteer subjects for part i must also be negative for hcv antibody.
Beschrijving

HIV Antibodies Seropositive | Hepatitis B Surface Antigens Seropositive | Hepatitis C Antibodies Negative

Datatype

boolean

Alias
UMLS CUI [1,1]
C0019683
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0019168
UMLS CUI [2,2]
C0521143
UMLS CUI [3,1]
C0166049
UMLS CUI [3,2]
C1513916
2. any medical condition that may interfere with the absorption, distribution or elimination of study drug (ppi-668), or with the clinical and laboratory assessments in this study.
Beschrijving

Medical condition Interferes with Absorption PPI-668 | Medical condition Interferes with Distribution PPI-668 | Medical condition Interferes with Elimination PPI-668 | Medical condition Interferes with Assessment

Datatype

boolean

Alias
UMLS CUI [1,1]
C3843040
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0237442
UMLS CUI [1,4]
C4508634
UMLS CUI [2,1]
C3843040
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0699903
UMLS CUI [2,4]
C4508634
UMLS CUI [3,1]
C3843040
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C0683141
UMLS CUI [3,4]
C4508634
UMLS CUI [4,1]
C3843040
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1516048
3. poorly controlled or unstable hypertension; or sustained systolic bp > 150 or diastolic bp > 95 at screen.
Beschrijving

Poor hypertension control | Hypertensive disease Unstable | Systolic Pressure | Diastolic blood pressure

Datatype

boolean

Alias
UMLS CUI [1]
C0421190
UMLS CUI [2,1]
C0020538
UMLS CUI [2,2]
C0443343
UMLS CUI [3]
C0871470
UMLS CUI [4]
C0428883
4. history of diabetes mellitus treated with insulin or hypoglycemic agents
Beschrijving

Diabetes Mellitus | Insulin regime | Hypoglycemic Agents

Datatype

boolean

Alias
UMLS CUI [1]
C0011849
UMLS CUI [2]
C0557978
UMLS CUI [3]
C0020616
5. history of alcohol abuse or illicit drug use which, in the investigator's judgment, could interfere with a patient's compliance, with the protocol requirements or with the safety or efficacy assessments of the study
Beschrijving

Alcohol abuse Interferes with Protocol Compliance | Illicit medication use Interferes with Protocol Compliance | Alcohol abuse Interferes with Evaluation | Illicit medication use Interferes with Evaluation

Datatype

boolean

Alias
UMLS CUI [1,1]
C0085762
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0525058
UMLS CUI [2,1]
C0281875
UMLS CUI [2,2]
C0521102
UMLS CUI [2,3]
C0525058
UMLS CUI [3,1]
C0085762
UMLS CUI [3,2]
C0521102
UMLS CUI [3,3]
C1261322
UMLS CUI [4,1]
C0281875
UMLS CUI [4,2]
C0521102
UMLS CUI [4,3]
C1261322
6. history of malignancy unless the malignancy has been in complete remission and without additional medical or surgical interventions during the preceding three years
Beschrijving

Malignant Neoplasms | Exception In complete remission

Datatype

boolean

Alias
UMLS CUI [1]
C0006826
UMLS CUI [2,1]
C1705847
UMLS CUI [2,2]
C0677874
7. no clinically significant laboratory abnormalities at screen for healthy volunteers in part i. for screen laboratory parameters for hcv patients in part ii, refer to the
Beschrijving

Healthy Volunteers | Laboratory test result abnormal Absent

Datatype

boolean

Alias
UMLS CUI [1]
C1708335
UMLS CUI [2,1]
C0438215
UMLS CUI [2,2]
C0332197
'additional criteria for hcv patients' below.
Beschrijving

Criteria Additional | Patients HCV

Datatype

boolean

Alias
UMLS CUI [1,1]
C0243161
UMLS CUI [1,2]
C1524062
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0220847
additional key entry criteria for hcv patients (part ii):
Beschrijving

Inclusion criteria Main Additional | Patients HCV

Datatype

boolean

Alias
UMLS CUI [1,1]
C1512693
UMLS CUI [1,2]
C1542147
UMLS CUI [1,3]
C1524062
UMLS CUI [2,1]
C0030705
UMLS CUI [2,2]
C0220847
1. clinical diagnosis of chronic hepatitis c, documented by:
Beschrijving

Hepatitis C, Chronic

Datatype

boolean

Alias
UMLS CUI [1]
C0524910
1. clinical findings compatible with chronic hepatitis c, and absence of other known liver disease
Beschrijving

Signs and Symptoms Consistent with Chronic Hepatitis C | Liver disease Other Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0037088
UMLS CUI [1,2]
C0332290
UMLS CUI [1,3]
C0524910
UMLS CUI [2,1]
C0023895
UMLS CUI [2,2]
C0205394
UMLS CUI [2,3]
C0332197
2. seropositive for hcv antibody or hcv rna at least once previously, and at screen
Beschrijving

Hepatitis C Antibodies Seropositive | Hepatitis C virus RNA Seropositive

Datatype

boolean

Alias
UMLS CUI [1,1]
C0166049
UMLS CUI [1,2]
C0521143
UMLS CUI [2,1]
C0369335
UMLS CUI [2,2]
C0521143
3. serum hcv rna > 5 log10 iu/ml at screen, by the pcr assay at the central study laboratory
Beschrijving

Hepatitis C virus RNA assay Serum Polymerase Chain Reaction

Datatype

boolean

Alias
UMLS CUI [1,1]
C1272251
UMLS CUI [1,2]
C0229671
UMLS CUI [1,3]
C0032520
4. hcv genotype-1 (1a or 1b, or non-subtypable genotype-1), or hcv genotype-2a or genotype-3a
Beschrijving

Hepatitis C virus genotype determination

Datatype

boolean

Alias
UMLS CUI [1]
C1533728
2. alt must be <5 x uln at screen
Beschrijving

Alanine aminotransferase measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0201836
3. no previous treatment with interferon, pegifn, or ribavirin for genotype-1 patients
Beschrijving

Patients Hepatitis C virus genotype determination | Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent

Datatype

boolean

Alias
UMLS CUI [1,1]
C0030705
UMLS CUI [1,2]
C1533728
UMLS CUI [2,1]
C3652465
UMLS CUI [2,2]
C0332197
UMLS CUI [3,1]
C0982327
UMLS CUI [3,2]
C0332197
UMLS CUI [4,1]
C0035525
UMLS CUI [4,2]
C0332197
4. no history of signs or symptoms of decompensated liver disease
Beschrijving

Sign or Symptom Absent Decompensated liver disease

Datatype

boolean

Alias
UMLS CUI [1,1]
C3540840
UMLS CUI [1,2]
C0332197
UMLS CUI [1,3]
C4075847
5. any of the following laboratory values at screening will be exclusionary for study participation:
Beschrijving

Laboratory Results Study Subject Participation Status Excluded

Datatype

boolean

Alias
UMLS CUI [1,1]
C1254595
UMLS CUI [1,2]
C2348568
UMLS CUI [1,3]
C0332196
hgb <11 g/dl in women or 12 g/dl in men.
Beschrijving

Hemoglobin measurement | Gender

Datatype

boolean

Alias
UMLS CUI [1]
C0518015
UMLS CUI [2]
C0079399
white blood cell count < 4,000/mm3.
Beschrijving

White Blood Cell Count procedure

Datatype

boolean

Alias
UMLS CUI [1]
C0023508
absolute neutrophil count (anc) < 1800 per mm3.
Beschrijving

Absolute neutrophil count

Datatype

boolean

Alias
UMLS CUI [1]
C0948762
platelet count < 100,000 per mm3.
Beschrijving

Platelet Count measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0032181
serum creatinine >uln at the central study laboratory.
Beschrijving

Serum creatinine raised

Datatype

boolean

Alias
UMLS CUI [1]
C0700225
serum albumin < 3.4 g/dl.
Beschrijving

Serum albumin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C0523465
total bilirubin > 2.0 mg/dl
Beschrijving

Serum total bilirubin measurement

Datatype

boolean

Alias
UMLS CUI [1]
C1278039
clinically significant abnormality in the electrocardiograms (ecgs) at screen
Beschrijving

Electrocardiogram abnormal

Datatype

boolean

Alias
UMLS CUI [1]
C0522055
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Similar models

Eligibility Hepatitis C, Chronic NCT01448200

1 Formulieren
Name
Type
Description | Question | Decode (Coded Value)
Datatype
Alias
Item Group
Inclusion criteria Main
Item
key inclusion criteria
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
Age | Female Sterilization | Postmenopausal state Duration
Item
1. male or female, between 18 and 65 years of age. female patients must be surgically sterile or two years post-menopausal.
boolean
C0001779 (UMLS CUI [1])
C0015787 (UMLS CUI [2])
C0232970 (UMLS CUI [3,1])
C0449238 (UMLS CUI [3,2])
Body mass index
Item
2. body mass index (bmi) 18 - 35 kg/m2
boolean
C1305855 (UMLS CUI [1])
Good health
Item
3. in good health, in the judgment of the principal investigator
boolean
C3813622 (UMLS CUI [1])
Protocol Compliance | Informed Consent
Item
4. able and willing to comply with all protocol requirements and to sign an informed consent.
boolean
C0525058 (UMLS CUI [1])
C0021430 (UMLS CUI [2])
Exclusion Criteria Main
Item
key exclusion criteria:
boolean
C0680251 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
HIV Antibodies Seropositive | Hepatitis B Surface Antigens Seropositive | Hepatitis C Antibodies Negative
Item
1. seropositive for hiv antibody, or hbv surface antigen (hbsag) at screen. volunteer subjects for part i must also be negative for hcv antibody.
boolean
C0019683 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0019168 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
C0166049 (UMLS CUI [3,1])
C1513916 (UMLS CUI [3,2])
Medical condition Interferes with Absorption PPI-668 | Medical condition Interferes with Distribution PPI-668 | Medical condition Interferes with Elimination PPI-668 | Medical condition Interferes with Assessment
Item
2. any medical condition that may interfere with the absorption, distribution or elimination of study drug (ppi-668), or with the clinical and laboratory assessments in this study.
boolean
C3843040 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0237442 (UMLS CUI [1,3])
C4508634 (UMLS CUI [1,4])
C3843040 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0699903 (UMLS CUI [2,3])
C4508634 (UMLS CUI [2,4])
C3843040 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C0683141 (UMLS CUI [3,3])
C4508634 (UMLS CUI [3,4])
C3843040 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1516048 (UMLS CUI [4,3])
Poor hypertension control | Hypertensive disease Unstable | Systolic Pressure | Diastolic blood pressure
Item
3. poorly controlled or unstable hypertension; or sustained systolic bp > 150 or diastolic bp > 95 at screen.
boolean
C0421190 (UMLS CUI [1])
C0020538 (UMLS CUI [2,1])
C0443343 (UMLS CUI [2,2])
C0871470 (UMLS CUI [3])
C0428883 (UMLS CUI [4])
Diabetes Mellitus | Insulin regime | Hypoglycemic Agents
Item
4. history of diabetes mellitus treated with insulin or hypoglycemic agents
boolean
C0011849 (UMLS CUI [1])
C0557978 (UMLS CUI [2])
C0020616 (UMLS CUI [3])
Alcohol abuse Interferes with Protocol Compliance | Illicit medication use Interferes with Protocol Compliance | Alcohol abuse Interferes with Evaluation | Illicit medication use Interferes with Evaluation
Item
5. history of alcohol abuse or illicit drug use which, in the investigator's judgment, could interfere with a patient's compliance, with the protocol requirements or with the safety or efficacy assessments of the study
boolean
C0085762 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0525058 (UMLS CUI [1,3])
C0281875 (UMLS CUI [2,1])
C0521102 (UMLS CUI [2,2])
C0525058 (UMLS CUI [2,3])
C0085762 (UMLS CUI [3,1])
C0521102 (UMLS CUI [3,2])
C1261322 (UMLS CUI [3,3])
C0281875 (UMLS CUI [4,1])
C0521102 (UMLS CUI [4,2])
C1261322 (UMLS CUI [4,3])
Malignant Neoplasms | Exception In complete remission
Item
6. history of malignancy unless the malignancy has been in complete remission and without additional medical or surgical interventions during the preceding three years
boolean
C0006826 (UMLS CUI [1])
C1705847 (UMLS CUI [2,1])
C0677874 (UMLS CUI [2,2])
Healthy Volunteers | Laboratory test result abnormal Absent
Item
7. no clinically significant laboratory abnormalities at screen for healthy volunteers in part i. for screen laboratory parameters for hcv patients in part ii, refer to the
boolean
C1708335 (UMLS CUI [1])
C0438215 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
Criteria Additional | Patients HCV
Item
'additional criteria for hcv patients' below.
boolean
C0243161 (UMLS CUI [1,1])
C1524062 (UMLS CUI [1,2])
C0030705 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Inclusion criteria Main Additional | Patients HCV
Item
additional key entry criteria for hcv patients (part ii):
boolean
C1512693 (UMLS CUI [1,1])
C1542147 (UMLS CUI [1,2])
C1524062 (UMLS CUI [1,3])
C0030705 (UMLS CUI [2,1])
C0220847 (UMLS CUI [2,2])
Hepatitis C, Chronic
Item
1. clinical diagnosis of chronic hepatitis c, documented by:
boolean
C0524910 (UMLS CUI [1])
Signs and Symptoms Consistent with Chronic Hepatitis C | Liver disease Other Absent
Item
1. clinical findings compatible with chronic hepatitis c, and absence of other known liver disease
boolean
C0037088 (UMLS CUI [1,1])
C0332290 (UMLS CUI [1,2])
C0524910 (UMLS CUI [1,3])
C0023895 (UMLS CUI [2,1])
C0205394 (UMLS CUI [2,2])
C0332197 (UMLS CUI [2,3])
Hepatitis C Antibodies Seropositive | Hepatitis C virus RNA Seropositive
Item
2. seropositive for hcv antibody or hcv rna at least once previously, and at screen
boolean
C0166049 (UMLS CUI [1,1])
C0521143 (UMLS CUI [1,2])
C0369335 (UMLS CUI [2,1])
C0521143 (UMLS CUI [2,2])
Hepatitis C virus RNA assay Serum Polymerase Chain Reaction
Item
3. serum hcv rna > 5 log10 iu/ml at screen, by the pcr assay at the central study laboratory
boolean
C1272251 (UMLS CUI [1,1])
C0229671 (UMLS CUI [1,2])
C0032520 (UMLS CUI [1,3])
Hepatitis C virus genotype determination
Item
4. hcv genotype-1 (1a or 1b, or non-subtypable genotype-1), or hcv genotype-2a or genotype-3a
boolean
C1533728 (UMLS CUI [1])
Alanine aminotransferase measurement
Item
2. alt must be <5 x uln at screen
boolean
C0201836 (UMLS CUI [1])
Patients Hepatitis C virus genotype determination | Interferon Absent | PEGINTERFERON Absent | Ribavirin Absent
Item
3. no previous treatment with interferon, pegifn, or ribavirin for genotype-1 patients
boolean
C0030705 (UMLS CUI [1,1])
C1533728 (UMLS CUI [1,2])
C3652465 (UMLS CUI [2,1])
C0332197 (UMLS CUI [2,2])
C0982327 (UMLS CUI [3,1])
C0332197 (UMLS CUI [3,2])
C0035525 (UMLS CUI [4,1])
C0332197 (UMLS CUI [4,2])
Sign or Symptom Absent Decompensated liver disease
Item
4. no history of signs or symptoms of decompensated liver disease
boolean
C3540840 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
C4075847 (UMLS CUI [1,3])
Laboratory Results Study Subject Participation Status Excluded
Item
5. any of the following laboratory values at screening will be exclusionary for study participation:
boolean
C1254595 (UMLS CUI [1,1])
C2348568 (UMLS CUI [1,2])
C0332196 (UMLS CUI [1,3])
Hemoglobin measurement | Gender
Item
hgb <11 g/dl in women or 12 g/dl in men.
boolean
C0518015 (UMLS CUI [1])
C0079399 (UMLS CUI [2])
White Blood Cell Count procedure
Item
white blood cell count < 4,000/mm3.
boolean
C0023508 (UMLS CUI [1])
Absolute neutrophil count
Item
absolute neutrophil count (anc) < 1800 per mm3.
boolean
C0948762 (UMLS CUI [1])
Platelet Count measurement
Item
platelet count < 100,000 per mm3.
boolean
C0032181 (UMLS CUI [1])
Serum creatinine raised
Item
serum creatinine >uln at the central study laboratory.
boolean
C0700225 (UMLS CUI [1])
Serum albumin measurement
Item
serum albumin < 3.4 g/dl.
boolean
C0523465 (UMLS CUI [1])
Serum total bilirubin measurement
Item
total bilirubin > 2.0 mg/dl
boolean
C1278039 (UMLS CUI [1])
Electrocardiogram abnormal
Item
clinically significant abnormality in the electrocardiograms (ecgs) at screen
boolean
C0522055 (UMLS CUI [1])
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