Study of Daclatasvir and TMC435 for subjects with genotype 1 chronic hepatitis C

• Conditions: Chronic Hepatitis C; MedDRA version: 14.1Level: LLTClassification code 10008912Term: Chronic hepatitis CSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Virus Diseases [C02]

• Registration Number: EUCTR2012-000070-28-HU
• Lead Sponsor: Bristol-Myers Squibb International Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-06-18
• Last Update Posted: 16 December 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 260

Inclusion Criteria

• HCV Genotype 1a or 1b;
• Males and females, = 18 years of age;
• HCV RNA > 10,000 IU/mL;
• Subjects with compensated cirrhosis are permitted.
• Advanced fibrosis (F3/F4) is capped at approximately 35% of the total treated population with a minimum of 20% F4 subjects.
• If no cirrhosis, a liver biopsy within 3 years prior to enrollment is required
• If cirrhosis is present, any prior liver biopsy is sufficient
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 234
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 26

Exclusion Criteria

Target Disease Exceptions
• Liver or any other transplant (other than cornea and hair):
• Evidence of a medical condition contributing to chronic liver disease other than HCV;
• Current or known history of cancer, (except situ carcinoma or adequately tx basal or squamous cell carcinoma of the skin) within 5 years prior to enrollment
• Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy;
• Subjects infected with HIV or HBV;
• Gastrointestinal disease impacting absorption of study drug;
• Uncontrolled diabetes or hypertension;

Medication related
• Prior treatment of HCV with HCV direct acting agent (DAA);
• Any criteria that would exclude the subject from receiving RBV.

Exclusion Laboratory results:

• Confirmed ANC < 1.5 billion cells/L (<1.2 billion cells/L for Black/African-Americans);
• Confirmed platelets < 90 billion cells/L;
• Confirmed hemoglobin < 12 g/dL for females or < 13 g/dL for males;
• ALT= 5 x ULN
• In subjects without cirrhosis, total bilirubin = 34 µmol/L (or = 2 mg/dL) unless subject has a documented history of Gilbert’s disease;
• In subjects with cirrhosis, total bilirubin = 26 µmol/L (or = 1.5 mg/dL);
• INR= 1.7
• QTcF or QTcB > 500 mSec
• CrCl= 50 mL/min
• AFP > 100 ng/mL OR
• AFP = 50 ng/mL and = 100 ng/mL requires a liver ultrasound (HCC are excluded)
• Albumin < 3.5 g/dL (35 g/L)

Study & Design

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