Clinical trial NCT01842451: A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Subjects With Genotype 1 Chronic Hepatitis C Chronic Hepatitis C
Official title: A Phase 2, Multicenter, Randomized, Partially-Blind, Dose-Ranging Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Chronic Hepatitis C
CHC
HCV
Hepatitis C
Lead sponsor: Vertex Pharmaceuticals Incorporated
Sponsor class: INDUSTRY
First posted: 2013-04-29
Enrollment: 23
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: A Phase 2 Study to Evaluate the Safety, Efficacy, Pharmacokinetics, and Pharmacodynamics of VX-135 and Daclatasvir in Treatment-Naïve Adult Subjects With Genotype 1 Chronic Hepatitis C


Eligibility criteria: Inclusion Criteria:

* Subjects must have genotype 1 CHC and evidence of HCV infection at least 6 months before screening
* Subjects must be treatment-naïve and have not received prior treatment with any interferon, immunomodulatory agent, or DAA for HCV

Exclusion Criteria:

* Evidence of cirrhosis
* History or other clinical evidence of significant or unstable cardiac disease
* Any other cause of significant liver disease in addition to hepatitis C
* Creatinine clearance ≤50 mL/min using the Cockcroft-Gault equation at screening
* Female subjects who are pregnant or nursing

Primary outcomes:
measure: The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments
timeFrame: Up to 64 weeks
Secondary outcomes:
measure: The proportion of subjects who have a sustained virologic response (SVR; i.e., HCV RNA concentration below the lower limit of quantitation [<LLOQ; <25 IU/mL]) at 4 weeks after the last planned dose of treatment (SVR4)
timeFrame: Up to 20 Weeks
measure: The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)
timeFrame: Up to 28 weeks
measure: The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)
timeFrame: Up to 40 weeks
measure: The proportion of subjects who have virologic relapse
timeFrame: Up to 64 weeks
measure: The proportion of subjects who have virologic breakthrough
timeFrame: Up to 16 weeks
measure: The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure
timeFrame: Up to 64 weeks
measure: The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)
timeFrame: Up to 28 weeks
measure: The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)
timeFrame: Up to 28 weeks
Other outcomes:
Locations:
city: Auckland
country: New Zealand
facility: New Zealand
city: Christchurch
country: New Zealand
facility: New Zealand
Study officials:
References: