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Completed

NCT Number: 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

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

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Key information

Conditions

Chronic Hepatitis C Blood-Borne Infections CHC Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections HCV Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Liver Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Virus Diseases

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

New Zealand, Auckland

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

VX-135

Drug

Daclatasvir

Drug

Primary outcomes

  1. The safety and tolerability as assessed by adverse events (AEs), vital signs, 12-lead electrocardiograms (ECGs), echocardiograms, and laboratory assessments

    Time frame: Up to 64 weeks

Secondary outcomes

  1. 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)

    Time frame: Up to 20 Weeks

  2. The proportion of subjects who have an SVR at 12 weeks after the last planned dose of treatment (SVR12)

    Time frame: Up to 28 weeks

  3. The proportion of subjects who have an SVR at 44 weeks after the last planned dose of treatment (SVR24)

    Time frame: Up to 40 weeks

  4. The proportion of subjects who have virologic relapse

    Time frame: Up to 64 weeks

  5. The proportion of subjects who have virologic breakthrough

    Time frame: Up to 16 weeks

  6. The amino acid sequence of the nonstructural NS5A and NS5B proteins in subjects who have treatment failure

    Time frame: Up to 64 weeks

  7. The proportion of subjects who achieve SVR12 by HCV genotype 1 subtype (1a versus non-1a)

    Time frame: Up to 28 weeks

  8. The proportion of subjects who achieve SVR12 by IL-28B genotype (CC versus non-CC)

    Time frame: Up to 28 weeks

Sponsors and collaborators

Lead sponsor

Vertex Pharmaceuticals Incorporated

Industry

Registry information

Official study 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

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Apr 29, 2013
Registry last updated
Dec 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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