A clinical investigation in the early stages of drug development to evaluate the safety and tolerability of a new drug for the treatment of hepatitis C when it is given to hepatitis C patients together with ribavirin.

• Conditions: Chronic Hepatitis C Viral Infection; MedDRA version: 13.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2011-000728-14-NL
• Lead Sponsor: Anadys Development, LTD

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-05-03
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 40

Inclusion Criteria

Male or female adults between 18 and 65 years of age, inclusive;

Patients should have chronic, documented, hepatitis C infection;

HCV genotype 1;

IL28B genotypic polymorphism CT;

Naïve to or have relapsed from prior pegylated interferon-alpha based therapy;

HCV RNA ³ 375,000 copies/mL or ³ 75,000 IU/mL;

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 40
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

FFemale patients who are pregnant or who are breast-feeding;

For treatment naïve patients: any previous treatment for HCV infection;

For patients who relapsed after prior pegylated interferon + ribavirin treatment: previous treatment with an experimental therapy for HCV infection;

History of cirrhosis on prior liver biopsy;

History of biochemical or other signs of decompensated liver disease:

History of hepatocellular carcinoma (HCC) or findings suggestive of possible HCC;

History of alcohol abuse and/or other drug addiction < 1 year prior to enrollment in the study or, a positive drug screen for amphetamines or cocaine;

Poorly-controlled diabetes mellitus;

Congestive heart failure or unstable cardiopulmonary condition, renal disease, or hemoglobinopathy;

History of seizure disorder;

History of severe psychiatric illness, including severe depression, history of suicidal ideation, suicidal attempts, or psychosis requiring medication;

Medical condition that requires use of systemic corticosteroids (e.g., severe asthma, severe arthritis or autoimmune conditions, organ transplantation, or adrenal insufficiency); corticosteroid nasal sprays, inhaled steroids for asthma and/or topical steroids are permissible;

Concurrent therapy with any immune-modulating agents, e.g., interleukins, interferons, vaccines, or immunosuppressive agents;

Received warfarin or other anticoagulants during the 21 days immediately prior to Screening, or is expected to require warfarin or other anticoagulants during the study;

One or more additional known primary or secondary causes of liver disease, other than hepatitis C;

Any other concurrent medical condition likely to preclude compliance with the schedule of evaluations, or likely to confound the efficacy or safety observations;

Any immunologically mediated disease (e.g., Crohn’s disease, ulcerative colitis);

History of a significant medical condition (except hepatitis C infection) that may interfere with the absorption, distribution, metabolism, or elimination of the study medication, or with the clinical and laboratory safety assessments in this study;

Malignancy within the last 5 years (squamous or basal cell skin cancers are allowed);

History of acute or chronic pancreatitis;

12-lead ECG showing Corrected QTc interval > 450 msec (Bazett’s correction), QRS > 120 msec, or Clinically significant abnormalities;

Donated or lost > 500 mL of blood < 30 days prior to enrollment into this study;

Participated in other clinical studies of a new chemical entity within 30 days prior to study randomization;

Active infection (cold, flu) within 14 days prior to the start of study or had a febrile illness within 5 days prior to administration of the first dose of study medication.

Any medical contraindications to Peg-INF or RBV therapy;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified