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Completed

NCT Number: NCT02094443

Alisporivir With RBV in Chronic Hepatitis C Genotype 2 and 3 Participants for Whom Interferon is Not an Option

The primary purpose of this study is to evaluate the pharmacodynamic (i.e. hepatitis C virus (HCV) viral load), pharmacokinetic and safety profiles between two treatment groups receiving different doses of DEB025 in combination with ribavirin (RBV) during the first 12 weeks treatment in chronic hepatitis C genotype (GT)-2 and GT-3 patients who had previously failed interferon therapy or were intolerant or unable to take interferon.

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Key information

Conditions

Hepatitis C Blood-Borne Infections Communicable Diseases Digestive System Diseases Flaviviridae Infections Hepatitis Hepatitis, Viral, Human Infections Liver Disease Liver Diseases RNA Virus Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Novartis Investigative Site, Clichy, France

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Written informed consent must be obtained before any assessment is performed
  • Participants with HCV genotype 2 or 3 infection who have previously failed interferon therapy or are intolerant or unable to take interferon
  • Males or females aged ≥18 years
  • Diagnosed Chronic hepatitis C virus infection

Exclusion criteria

  • Use of other investigational drugs at the time of enrollment, or within 30 days or 5 half-lives of that medication before enrollment
  • History of hypersensitivity to any of the study drugs or to drugs of similar chemical classes
  • Hepatitis B surface antigen (HBsAg) positive
  • Human immunodeficiency virus (HIV) positive

Other protocol-defined inclusion/exclusion criteria apply.

Treatment and study plan

Alisporivir

Drug

ALV 100 and 200 mg soft gel capsules administered orally

Other names: DEB025

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®

Primary outcomes

  1. Change From Baseline in Hepatitis C Virus Ribonucleic Acid Viral Load at Week 12

    Time frame: Baseline, Week 12

    The change in log transformed Hepatitis-C Virus (HCV) Ribonucleic acid (RNA) from baseline to Week 12.

  2. Change From Baseline in Alanine Aminotransferase (ALT) at Week 12

    Time frame: Baseline, Week 12

    ALT levels were assessed as part of clinical chemistry assessments throughout the study as a measure of biochemical liver recovery. A negative change from baseline indicates less liver damage.

Secondary outcomes

  1. Percentage of Participants Achieving Sustained Virologic Response (SVR) 4, 12, and 24 Weeks After Treatment

    Time frame: Up to 24 weeks posttreatment

    SVR is defined as HCV RNA less than the lower limit of quantification (LLOQ), i.e., <15 IU/mL, at 4 weeks (SVR4), 12 weeks (SVR12), and 24 weeks (SVR24) after treatment, respectively.

  2. Percentage of Participants With Extended Rapid Virologic Response

    Time frame: 2 weeks

    Extended rapid virologic response (eRVR) was defined as serum HCV RNA < LLOQ after 2 weeks of treatment

  3. Percentage of Participants With Rapid Virologic Response (RVR)

    Time frame: 4 weeks

    eRVR was defined as serum HCV RNA < LLOQ after 4 weeks of treatment

  4. Percentage of Participants With End of Treatment Response (ETR)

    Time frame: Up to 24 weeks

    ETR was defined as serum HCV RNA < LLOQ at treatment end (completed or prematurely discontinued).

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

    Time frame: Up to 24 weeks

    ALT is an enzyme found mostly in the cells of the liver and kidney. When the liver is damaged, ALT is released into the blood. This makes ALT a common test for liver damage, because higher ALT levels may indicate more liver damage. ALT upper limit of normal is commonly considered to be 40 international units per liter (IU/L), so abnormal ALT is above 40 IU/L.

Sponsors and collaborators

Lead sponsor

Debiopharm International SA

Industry

Registry information

Official study title

A Multicenter, Open-label, Randomized, 2-arm, Phase II Trial of Pharmacodynamics, Pharmacokinetics and Safety of Two Dose Regimens of DEB025/Alisporivir in Combination With Ribavirin Therapy in Chronic Hepatitis C Genotype 2 and 3 Patients Who Have Previously Failed Interferon Therapy or Are Intolerant or Unable to Take Interferon.

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Mar 21, 2014
Registry last updated
Oct 13, 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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