Safety Study of Pegylated Interferon Lambda Plus Single or 2 Direct Antiviral Agents With Ribavirin (D-LITE)

Bristol-Myers Squibb (BMS)

Status and phase: Completed; Phase 2

Conditions: Hepatitis C

Treatments: Biological: Pegylated Interferon Lambda; Drug: Daclatasvir; Drug: Ribasphere

Study type: Interventional

Funder types: Industry

Identifiers

NCT01795911

AI452-008 (Substudy Part C)

2010-022568-11 (EudraCT Number)

Details and patient eligibility

About

Substudy C: The purpose of this substudy is to determine whether Lambda combined with Ribavirin and Daclatasvir for 12 weeks is efficacious in treatment naïve subjects with genotype 1b chronic HCV infection

Enrollment: 165 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Chronic Hepatitis C, Genotype 1
• HCV RNA >100,000 IU/mL at screening;
• Seronegative for Human immunodeficiency virus (HIV) and Hepatitis B surface antigen (HBsAg);
• Liver biopsy within prior 2 years; subjects with compensated cirrhosis can enroll and will be capped at approximately 10%

Exclusion criteria

• Any evidence of liver disease other than HCV;
• Co-infection with HIV;
• Diagnosed or suspected hepatocellular carcinoma;
• Medical history or laboratory value abnormalities that would prohibit the use of Pegylated Interferon Alpha-2a or Ribavirin

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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165 participants in 1 patient group

Substudy C: Pegylated Interferon Lambda+Ribasphere+Daclatasvir

Experimental group

Description:

Pegylated Interferon Lambda 180 μg Solution, Subcutaneous Once weekly for 12 weeks; Ribasphere 1000 mg for subjects weighing \< 75 kg and 1200 mg for subjects weighing ≥ 75 kg oral tablets per day \[subjects should take either 400 mg for subjects \< 75 kg or 600 mg ≥ 75 kg in the morning with food and 600 mg in the evening with food\] for 12 weeks; Daclatasvir 60 mg oral tablet Once daily for 12 weeks

Treatment:

Drug: Ribasphere

Drug: Daclatasvir

Biological: Pegylated Interferon Lambda