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Completed

NCT Number: NCT01215643

Efficacy and Safety of Alisporivir Alone or Combined With RBV or PEG in Chronic Hepatitis C Genotype 2 and 3 Treatment-naïve Participants

The study is to investigate whether alisporivir (ALV; DEB025) alone or in combination with either ribavirin (RBV) or peginterferon alfa-2a (PEG) is more efficient compared to standard of care (PEG+RBV) in treatment-naïve participants with hepatitis C virus (HCV) genotype 2 and 3. In addition, triple therapy with DEB025 plus standard of care will be applied to participants not achieving rapid viral response (RVR) in the different arms.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Chronic Pain Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms RNA Virus Infections Signs and Symptoms 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 hepatitis C viral infection
  • Plasma HCV RNA level lower limit ≥ 10,000 IU/ml assessed by quantitative polymerase chain reaction (qPCR) or equivalent at screening (no upper limit)
  • HCV genotype 2 or 3
  • No previous treatment for hepatitis C infection

Exclusion criteria

  • Evidence of cirrhosis at the time of screening
  • Evidence of hepatocellular carcinoma at the time of screening
  • Any other cause of relevant liver disease other than HCV
  • Alanine aminotransferase (ALT) ≥ 10 times upper limit of normal (ULN)
  • 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 400 mg (2 x 200 mg tablets) administered orally twice daily (BID)

Other names: Copegus®, RBV

Primary outcomes

  1. Percentage of Participants With Rapid Viral Response (RVR) After 4 Weeks of Treatment < the Limit of Quantification (RVR4LOQ)

    Time frame: after 4 weeks of treatment

    RVR4LOQ was defined as RVR [serum hepatitis C virus (HCV) ribonucleic acid (RNA) < the limit of quantification (LOQ), i.e., < 25 IU/mL], after 4 weeks of treatment.

Secondary outcomes

  1. Percentage of Participants With RVR After 4 Weeks of Treatment < the Limit of Detection (RVR4LOD)

    Time frame: after 4 weeks of treatment

    RVR4LOD was defined as Rapid Viral Response (RVR) [serum HCV RNA < the limit of detection (LOD), i.e., < 10 IU/mL], after 4 weeks of treatment.

  2. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 2)

    Time frame: after 4 weeks of treatment

  3. Percentage of Participants With RVR4LOQ and RVR4LOD (Genotype 3)

    Time frame: after 4 weeks of treatment

  4. Percentage of Participants With Complete Early Viral Response (cEVR) After 12 Weeks of Treatment (cEVR12LOQ and cEVR12LOD)

    Time frame: after 12 weeks of treatment

    cEVR12LOQ and cEVR12LOD were defined as cEVR [serum HCV RNA < LOQ and < LOD] after 12 weeks of treatment, respectively.

  5. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 2)

    Time frame: after 12 weeks of treatment

  6. Percentage of Participants With cEVR12LOQ and cEVR12LOD (Genotype 3)

    Time frame: after 12 weeks of treatment

  7. Percentage of Participants With End of Treatment Response (ETR) Within 24 Weeks (ETR24LOQ and ETR24LOD)

    Time frame: at end of treatment, within 24 weeks

    ETR24LOQ and ETR24LOD were defined as ETR [serum HCV RNA < LOQ and < LOD] after 24 weeks of treatment or when prematurely discontinued.

  8. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 2)

    Time frame: at end of treatment, within 24 weeks

  9. Percentage of Participants With ETR24LOQ and ETR24LOD (Genotype 3)

    Time frame: at end of treatment, within 24 weeks

  10. Percentage of Participants With RVR Who Achieved Sustained Viral Response (SVR) 12 Weeks After the End of Treatment (SVR12LOQ and SVR12LOD)

    Time frame: 12 weeks after the end of treatment

    SVR12LOQ and SVR12LOD were defined as Sustained Viral Response (SVR) [serum HCV RNA < LOQ and < LOD] 12 weeks after treatment, respectively.

  11. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 2)

    Time frame: 12 weeks after the end of treatment

  12. Percentage of Participants With RVR Who Achieved SVR12LOQ and SVR12LOD (Genotype 3)

    Time frame: 12 weeks after the end of treatment

  13. Percentage of Participants With RVR Who Achieved SVR at 24 Weeks After the End of Treatment (SVR24LOQ and SVR24LOD)

    Time frame: 24 weeks after the end of treatment

  14. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 2)

    Time frame: 24 weeks after the end of treatment

  15. Percentage of Participants With RVR Who Achieved SVR24LOQ and SVR24LOD (Genotype 3)

    Time frame: 24 weeks after the end of treatment

  16. Percentage of Participants With On-treatment Viral Breakthrough

    Time frame: within 24 weeks of 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 (< LOD) during treatment

  17. Percentage of Participants With Viral Relapse

    Time frame: within 24 weeks after the end of treatment

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

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

A Multicenter, Randomized, Open Label, Parallel-group Phase IIB Study on the Efficacy and Safety of Oral Regimens of DEB025 Alone or in Combination With Ribavirin Versus Standard of Care (Peg-IFNα2a Plus Ribavirin) in Treatment-naïve Hepatitis C Genotype 2 and 3 Patients

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Oct 6, 2010
Registry last updated
Aug 30, 2016

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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