ID
36445
Beschrijving
Herpes Simplex Type 1 Suppression in Hepatitis C; ODM derived from: https://clinicaltrials.gov/show/NCT01580995 Brief Summary: The purpose of this study is to examine the effects of valacyclovir in patients who have chronic hepatitis C, antibodies to herpes simplex type 1 infection but do not have antibodies to herpes simplex type 2 infection. Herpes simplex type 1 infection commonly causes cold sores or fever blisters, also known as herpes labialis, but most persons do not have any symptoms at all. Valacyclovir is a medication which is approved by the Food and Drug administration to treat herpes labialis. Valacyclovir has not been approved to treat chronic hepatitis C infection. The study will take 16 weeks. Participants will be assigned to take either the study drug, valacyclovir, or a sugar pill that looks exactly like valacyclovir. The researchers and patients will not know which medication they are receiving. Study visits will occur every two weeks and will take approximately 30-45 minutes. All study visits will occur at the G.V. Sonny Montgomery VA Medical Center in Jackson, Mississippi.
Link
https://clinicaltrials.gov/show/NCT01580995
Trefwoorden
Versies (2)
- 15-01-19 15-01-19 -
- 14-05-19 14-05-19 -
Houder van rechten
VA Office of Research and Development
Geüploaded op
14 mei 2019
DOI
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Licentie
Creative Commons BY-NC 3.0
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Herpes Simplex Type 1 Suppression in Hepatitis C NCT01580995
Eligibility Criteria
- StudyEvent: Eligibility
Beschrijving
Exclusion Criteria
Alias
- UMLS CUI
- C0680251
Beschrijving
The participant should not have had antiherpes or immunomodulatory therapy during the past 30 day
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C1514463
- UMLS CUI [1,2]
- C0019369
- UMLS CUI [1,3]
- C0332185
- UMLS CUI [2,1]
- C1963758
- UMLS CUI [2,2]
- C0332185
Beschrijving
The participant should not have hiv or chronic hepatitis b infection
Datatype
boolean
Alias
- UMLS CUI [1]
- C0019693
- UMLS CUI [2]
- C0524909
Beschrijving
The participant should not have decompensated liver disease (ascites, hepatic encephalopathy, coagulopathy, jaundice/icterus)
Datatype
boolean
Alias
- UMLS CUI [1]
- C4075847
- UMLS CUI [2]
- C0003962
- UMLS CUI [3]
- C0019151
- UMLS CUI [4]
- C0005779
- UMLS CUI [5]
- C0022346
Beschrijving
The participant should not have a creatinine clearance <50 ml/min.
Datatype
boolean
Alias
- UMLS CUI [1]
- C0373595
Beschrijving
The (female) participant should not be pregnant or nursing
Datatype
boolean
Alias
- UMLS CUI [1]
- C0032961
- UMLS CUI [2]
- C0006147
Beschrijving
The participant should not have a gastrointestinal disorder which might result in malabsorption of valacyclovir
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0017178
- UMLS CUI [1,2]
- C3714745
- UMLS CUI [1,3]
- C0249458
Beschrijving
The participant should not have a history of erythema multiforme major, thrombotic thrombocytopenia purpura or hemolytic uremic syndrome
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0262926
- UMLS CUI [1,2]
- C0857305
- UMLS CUI [2,1]
- C0262926
- UMLS CUI [2,2]
- C0019061
- UMLS CUI [3,1]
- C0262926
- UMLS CUI [3,2]
- C3241919
Beschrijving
The participant should not have an allergy to valacyclovir or related drug
Datatype
boolean
Alias
- UMLS CUI [1,1]
- C0249458
- UMLS CUI [1,2]
- C0020517
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Eligibility Criteria
- StudyEvent: Eligibility
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C0392762 (UMLS CUI [1,3])
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C0205160 (UMLS CUI [1,2])
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C0019151 (UMLS CUI [3])
C0005779 (UMLS CUI [4])
C0022346 (UMLS CUI [5])
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C3714745 (UMLS CUI [1,2])
C0249458 (UMLS CUI [1,3])
C0857305 (UMLS CUI [1,2])
C0262926 (UMLS CUI [2,1])
C0019061 (UMLS CUI [2,2])
C0262926 (UMLS CUI [3,1])
C3241919 (UMLS CUI [3,2])
C0020517 (UMLS CUI [1,2])