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Completed

NCT Number: NCT01183169

Efficacy and Safety of Adding Alisporivir (DEB025) to Peginterferon (IFN) Alfa-2a (Peg-IFN Alfa-2a) and Ribavirin in Chronic HCV Genotype 1 Patients Who Relapsed or Did Not Respond to Previous Treatment

The study is to investigate whether participants with hepatitis C virus (HCV) genotype 1 who have a history of non-response/relapse to peginterferon alfa-2a (PEG) and ribavirin (RBV) may benefit from treatment with triple therapy alisporivir (ALV; DEB025) with PEG and RBV versus placebo with PEG and RBV.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Disease Communicable Diseases Digestive System Diseases Disease Attributes Flaviviridae Infections Hepatitis 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Kingswood, New South Wales, Australia

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Chronic HCV genotype 1 viral infection
  • HCV RNA ≥ 1,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening
  • Previous non-responders/relapsers to PEG and RBV after treatment for at least 12 weeks

Exclusion criteria

  • Treatment with any anti-HCV drug (whether approved or investigational) within 3 months prior to screening
  • Women of child-bearing potential unless using highly effective
  • Any other cause of relevant liver disease other than HCV
  • Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Alisporivir

Drug

ALV 200 mg soft gel capsules administered orally

Other names: DEB025, ALV

Peginterferon alfa-2a

Drug

PEG 180 μg administered via subcutaneous (s.c.) injection once weekly

Other names: Pegasys®, PEG

Ribavirin

Drug

RBV 200 mg tablets (weight-based dose: < 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Other names: Copegus®, RBV

Placebo

Drug

ALV placebo soft gel capsules administered orally

Other names: ALV Placebo

Primary outcomes

  1. Percentage of Participants With Complete Early Viral Response Below the Limit of Quantification (cEVR-LOQ)

    Time frame: after 12 weeks of treatment

    cEVR-LOQ was defined as serum HCV RNA below the limit of quantification (< LOQ; i.e., 25 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

Secondary outcomes

  1. Percentage of Participants With Complete Early Viral Response Below the Limit of Detection (cEVR-LOD)

    Time frame: after 12 weeks of treatment

    cEVR-LOD was defined as serum HCV RNA below the limit of detection (< LOD; i.e., 10 IU/mL) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

  2. Percentage of Participants Who Achieved Sustained Viral Response 12 Weeks After Treatment (SVR12)-LOQ and SVR12-LOD

    Time frame: 12 weeks after treatment

    SVR12-LOQ and SVR12-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 12 weeks after treatment, respectively.

  3. Percentage of Participants Who Achieved Sustained Viral Response 24 Weeks After Treatment (SVR24)-LOQ and SVR24-LOD

    Time frame: 24 weeks after treatment

    SVR24-LOQ and SVR24-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD 24 weeks after treatment, respectively.

  4. Percentage of Participants With Rapid Viral Response (RVR)-LOQ and RVR-LOD

    Time frame: after 4 weeks of treatment

    RVR-LOQ and RVR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD after 4 weeks of treatment, respectively. Post-switch groups were assessed 4 weeks after the switch.

  5. Percentage of Participants With Partial Early Virologic Response After 12 Weeks of Treatment (pEVR)-LOQ and pEVR-LOD

    Time frame: after 12 weeks of treatment

    pEVR-LOQ and pEVR-LOD were defined as a ≥ 2 log10 decrease in HCV RNA and still detectable (≥ LOQ and ≥ LOD, respectively) after 12 weeks of treatment. Post-switch groups were assessed 12 weeks after the switch.

  6. Percentage of Participants With End of Treatment Response (ETR)-LOQ and ETR-LOD

    Time frame: within 48 weeks

    ETR-LOQ and ETR-LOD were defined as serum HCV RNA < LOQ and serum HCV RNA < LOD at treatment end (completed or prematurely discontinued), respectively.

  7. Percentage of Participants With Abnormal Alanine Aminotransferase (ALT) at Baseline Who Had Normalized ALT at Treatment End and Study End

    Time frame: Up to 48 weeks

  8. Percentage of Participants With On-treatment Viral Breakthrough

    Time frame: within 48 weeks

    On-treatment viral breakthrough was defined as either:

    • Confirmed increase of HCV RNA ≥1 log10 above nadir (nadir = lowest HCV RNA value during treatment), or
    • HCV RNA becoming ≥ 100 IU/mL after previously being undetectable (< LOQ) during treatment

  9. Percentage of Participants With Viral Relapse

    Time frame: within 24 weeks after treatment

    Viral relapse was defined as reappearance of detectable HCV RNA after previously being undetectable (< LOQ) during treatment.

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Study on Efficacy and Safety of DEB025 Combined With Peg-IFN Alfa-2a and Ribavirin in Chronic Hepatitis C Genotype 1 Relapsers and Non-responders to Previous Peg-IFN Alfa-2 Plus Ribavirin Treatment

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Aug 17, 2010
Registry last updated
Aug 25, 2016

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

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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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