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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01842451

Enrollment

Registered

2013-04-29

Start date

2013-06-30

Completion date

2014-05-31

Last updated

2015-12-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CHC, Chronic Hepatitis C, HCV, Hepatitis C

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

Interventions

DRUGVX-135

DRUGDaclatasvir

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments	Up to 64 weeks

Secondary

Measure	Time frame
The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)	Up to 28 weeks
The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)	Up to 40 weeks
The proportion of subjects who have virologic relapse	Up to 64 weeks
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)	Up to 20 Weeks
The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure	Up to 64 weeks
The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)	Up to 28 weeks
The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)	Up to 28 weeks
The proportion of subjects who have virologic breakthrough	Up to 16 weeks

Countries

New Zealand

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026