Phase III China GT 1b Interferon (IFN) Intolerant Prev Exclude Dual

Bristol-Myers Squibb (BMS)

Status and phase

Completed

Phase 3

Conditions

Hepatitis C

Treatments

Drug: Daclatasvir

Drug: Asunaprevir

Study type

Interventional

Funder types

Industry

Identifiers

NCT01995266

AI447-036

Details and patient eligibility

About

Patients with chronic hepatitis genotype 1b, who are intolerant or ineligible to Interferon alfa therapy with or without Ribavirin, will be treated for 24 weeks with Daclatasvir (DCV) Dual regimen (= Daclatasvir + Asunaprevir) and followed for an additional 24 weeks post-treatment in order to determine the safety and efficacy of the DCV DUAL regimen

Enrollment

218 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

Males and females, ≥ 18 years of age
Subjects chronically infected with HCV Genotype (GT)-1b only as documented by positive HCV RNA and anti-HCV antibody at screening and either:
1. Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
  
  or
2. Liver biopsy consistent with chronic HCV infection (evidence of fibrosis and/or inflammation)
Subjects who are intolerant to previous therapy with Interferon Alfa (IFNα) either with or without Ribavirin (RBV) (I±R)(independent of previous response to therapy) or ineligible for I±R and who meet one of the criteria below:
1. Anemia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in hemoglobin to < 8.5 g/dL during therapy (documented); the I±R ineligibles are subjects who have a screening hemoglobin < 10.0 g/dL and ≥ 8.5 g/dL
  
  OR
2. Neutropenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in absolute neutrophil count (ANC) to < 0.5 x 10(9) during therapy (documented); the I±R ineligibles are subjects who have a screening ANC < 1.5 x 10(9) cells/L and ≥ 0.5 x 10(9) cells/L
  
  OR
3. Thrombocytopenia: the I±R intolerants are subjects who were previously treated with IFNα/RBV therapy and had a decline in platelet counts < 25,000 cells/mm3 during therapy (documented); the I±R ineligibles are subjects who have a screening platelet count of < 90 x 10(9) cells/L and ≥ 50 x 10(9) cells/L
HCV RNA ≥ 10,000 IU/mL
Seronegative for Human Immunodeficiency Virus (HIV) and hepatitis B surface antigen (HBsAg)
Body Mass Index (BMI) of 18 to 35 kg/m2, inclusive. BMI = weight (kg)/ [height(m)]2 at screening
Subjects with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately 40%). If a subject does not have cirrhosis, a liver biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If cirrhosis is present, any prior liver biopsy is sufficient. For countries where liver biopsy is not required prior to treatment and where noninvasive imaging tests (Fibroscan® ultrasound) are approved for staging of liver disease, non-invasive imaging test results may be used to assess the extent of liver disease

Exclusion Criteria:

Prior treatment with HCV direct acting antiviral (DAA)
Evidence of a medical condition contributing to chronic liver disease other than HCV
Evidence of decompensated liver disease including, but not limited to, a history or presence of ascites, bleeding varices, or hepatic encephalopathy
Diagnosed or suspected hepatocellular carcinoma or other malignancies
Uncontrolled diabetes or hypertension
History of moderate to severe depression. Well-controlled mild depression is allowed
Total bilirubin ≥ 34 µmol/L (or ≥ 2 mg/dL) unless subject has a documented history of Gilbert's disease
Confirmed alanine aminotransferase (ALT) ≥ 5 x upper limit of normal (ULN)
Confirmed albumin < 3.5 g/dL (35 g/L)
Alpha-fetoprotein (AFP) > 100 ng/mL OR ≥ 50 and ≤ 100 ng/mL requires a liver ultrasound and subjects with findings suspicious of hepatocellular carcinoma (HCC) are excluded
Confirmed hemoglobin < 8.5 g/dL
Confirmed ANC < 0.5 x 10(9) cells/L
Confirmed platelet count < 50,000 cells/mm3