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Eligibility Hepatitis C NCT00633243

- 20/09/2021 - 1 Formulaire, 2 Groupes Item, 11 Eléments de données, 1 Langue
Groupes Item: Inclusion Criteria, Exclusion Criteria
Effective Treatment of Hepatitis C in Substance Users; ODM derived from: https://clinicaltrials.gov/show/NCT00633243

Eligibility Hepatitis C NCT00911963

- 07/10/2020 - 1 Formulaire, 2 Groupes Item, 9 Eléments de données, 1 Langue
Groupes Item: Inclusion Criteria, Exclusion Criteria
Pharmacokinetics of Multiple Ascending Doses of VCH-222 in Subjects With Chronic Hepatitis C Infection; ODM derived from: https://clinicaltrials.gov/show/NCT00911963

VX-950HPC3006 NCT01571583 Final rash/cutaneous event evaluation

- 31/03/2016 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: final rash/cutaneous event evaluation
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Trial Completion

- 31/03/2016 - 1 Formulaire, 1 Groupe Item, 2 Eléments de données, 1 Langue
Groupe Item: Trial completion
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Blood sample for local analysis

- 31/03/2016 - 1 Formulaire, 25 Groupes Item, 193 Eléments de données, 1 Langue
Groupes Item: Blood sample for local analysis, Hemoglobin, Hematocrit, RBC Count, MCH, MCHC, MCV, RBC Morphology, Platelet Count, Reticulocyte Count, WBC Count, Neutrophil Count, Neutrophil Percentage, Lymphocyte Count, Lymphocyte Percentage, Eosinophils Count, Eosinophils Percentage, Monocyte Count, Monocytes Percentage, Basophils Count, Basophils Percentage, AST, ALT, Creatinine, Additional clinically significant results entry
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Vital Signs / Anthropometric Measurements [FRMVS_VSRASH]

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: Vital signs and anthropometric measurements
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Local Laboratory [FRMLB_LOCLABUNS1]

- 30/03/2016 - 1 Formulaire, 2 Groupes Item, 13 Eléments de données, 1 Langue
Groupes Item: Date of sampling, Local laboratory results entry
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Biopsy [FRMBIOPSYUNS] - VX-950HPC3006 NCT01571583 BiopsyVX-950HPC3006 NCT01571583 Biopsy [FRMBIOPSYUNS]

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Liver Graft Biopsy Result
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 PK Sampling TAC/CsA (Uns)

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 7 Eléments de données, 1 Langue
Groupe Item: PK Sampling TAC/CsA (Uns)
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 PK Sampling TVR (Uns)

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 4 Eléments de données, 1 Langue
Groupe Item: PK sampling TVR
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB6]

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 6 Eléments de données, 1 Langue
Groupe Item: Laboratory blood urine pregnancy
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

VX-950HPC3006 NCT01571583 Laboratory - blood, urine, pregnancy (central lab) (lab) [FRMRF_LAB3]

- 30/03/2016 - 1 Formulaire, 1 Groupe Item, 5 Eléments de données, 1 Langue
Groupe Item: Laboratory blood urine pregnancy
This is an open-label (all people know the identity of the intervention), multicenter study in genotype 1 chronic HCV infected liver transplant patients who will be treated for 12 weeks with telaprevir 750 mg every 8 hours given in combination with Peg-IFN-alfa-2a and ribavirin followed by 36 weeks of treatment with Peg-IFN-alfa-2a and ribavirin alone. The total treatment duration will be 48 weeks. Safety will be evaluated throughout the study and will include evaluations of adverse events, clinical laboratory tests, electrocardiogram, vital signs, and physical examination. NCT01571583

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