Efficacy and Safety Evaluation of a Regimen Consisting of Peginterferon Lambda-1a + Ribavirin + Daclatasvir (Lambda + RBV + DCV) in HCV Genotype 1b Treatment naïve Patients or Prior Relapsers to Peginterferon Alfa + Ribavirin (Alfa + RBV) Therapy
Status: | Completed |
---|---|
Conditions: | Hepatitis |
Therapuetic Areas: | Immunology / Infectious Diseases |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 4/21/2016 |
Start Date: | January 2013 |
End Date: | October 2014 |
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 (the STRUCTURE Study)
The purpose of this study is to determine if treatment with Pegylated Interferon Lambda-1a,
given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective
as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in
subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received
any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment
with Pegylated Interferon Alfa + Ribavirin
given in combination with Ribavirin and Daclatasvir for 24 weeks, is as safe and effective
as the standard treatment with Pegylated Interferon Alfa-2a + Ribavirin + Telaprevir in
subjects who are infected with Chronic Hepatitis C virus genotype 1b and have never received
any prior anti-HCV treatment, or who have relapsed after an initial, successful treatment
with Pegylated Interferon Alfa + Ribavirin
Inclusion Criteria:
- Patients chronically infected with HCV Genotype-1b
- Naïve to prior treatment or documented evidence of relapse after completion of the
prescribed duration of treatment (duration may be 24 or 48 weeks, to be determined
based upon local guidelines)
- HCV RNA viral load ≥100,000 IU/mL at screening
- Patients with compensated cirrhosis are permitted
Exclusion Criteria:
- Infection with Hepatitis C virus (HCV) other than Genotype-1b
- Positive Hepatitis B surface antigen (HBsAg) or Human immunodeficiency virus
(HIV)-1/HIV-2 antibody test at screening
- Evidence of chronic liver disease caused by diseases other than chronic HCV infection
- Current evidence of or history of variceal bleeding, hepatic encephalopathy, or
ascites requiring diuretics or paracentesis or evidence of any of these findings on
physical examination performed at screening
- Current or known history of cancer (except adequately treated in situ carcinoma of
the cervix, or basal or squamous cell carcinoma of the skin) within 5 years prior to
screening
- Current evidence or known history of decompensated cirrhosis based on radiologic
criteria or biopsy results and clinical criteria
- Laboratory values:
1. Hemoglobin <12.0 g/dL (males) or <11.0 g/dL (females)
2. Platelets <90,000/mm3
3. Total serum bilirubin ≥2 mg/dL (unless due to Gilbert's disease)
We found this trial at
9
sites
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Premier Medical Group of the Hudson Valley Premier Medical Group offers comprehensive, integrated care providing...
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