Clinical Trial:

Hepatitis C Lambda study

Full Name

Hepatitis C (AI452021): A phase 3 evaluation of daclatasvir in combination with peginterferon lambda-1a and ribavirin (RBV) or telaprevir in combination with peginterferon alfa-2a and RBV in patients with chronic hepatitis C genotype 1b who are treatment naïve or prior relapsers to alfa/RBV therapy (1_PRO00000692)

Description

Participants will be randomized to 1 of 2 study medication groups: Lambda + ribavirin + daclatasvir (Group 1) or alfa + ribavirin + telaprevir (Group 2). There will be twice as many participants assigned to Group 1. Both the lambda and the alfa medications are self-injected under the skin once a week; all other medications are taken by mouth. Blood samples will be taken periodically to test immune system response. Duration of the study is expected to be 48 to 72 weeks, including post-treatment follow-up. There is also an optional pharmacogenetic (study of genes) sub-study where, if participants agree, they will provide an additional blood sample and health information. Participants can take part in the main study without taking part in the pharmacogenetic sub-study.

Eligibility

Inclusion Criteria
  • Age of 18 years or older
  • Documented chronic infection with HCV GT-1b
  • Appropriate blood levels
  • No prior treatment, or documented relapse after prior treatment, with alpha/RBV
  • Cannot be pregnant or breastfeeding
  • Must use 2 highly effective methods of contraception for study duration and up to 24 weeks after last dose of study drugs or RBV
Doctor(s) Running This Study

Specialties

  • Infectious Diseases
  • Internal Medicine

Area of focus i

  • Hepatitis Care
  • HIV Care
  • HIV Pre-exposure Prophylaxis (PrEP)
  • LGBTQ+ Patient Support
  • Transgender health

LVPG Cliniciani

Accepting New Patients