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

NCT ID: NCT01995266

Last Updated: 2020-08-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 218 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-07-31

Brief Summary

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

Conditions

Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Asunaprevir + Daclatasvir

Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and

Daclatasvir 60mg tablet by mouth once daily for 24 weeks

Group Type: EXPERIMENTAL

Asunaprevir

Intervention Type: DRUG

Daclatasvir

Intervention Type: DRUG

Interventions

Asunaprevir

Intervention Type: DRUG

Daclatasvir

Intervention Type: DRUG

Other Intervention Names

BMS-650032; BMS-790052

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bristol-Myers Squibb

Role: STUDY_DIRECTOR

Bristol-Myers Squibb

Locations

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Beijing Municipality, China

Local Institution

Beijing, Guangdong, China

Local Institution

Chongqing, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Guangzhou, Guangdong, China

Local Institution

Wuhan, Hubei, China

Local Institution

Changsha, Hunan, China

Local Institution

Changsha, Hunan, China

Local Institution

Nanjing, Jiangsu, China

Local Institution

Nanjing, Jiangsu, China

Local Institution

Nanjing, Jiangsu, China

Local Institution

Changchun, Jilin, China

Local Institution

Shenyang, Liaoning, China

Local Institution

Xi'an, Shan3xi, China

Local Institution

Xi'an, Shan3xi, China

Local Institution

Shanghai, Shanghai Municipality, China

Local Institution

Shanghai, Shanghai Municipality, China

Local Institution

Beijing, Shanxi, China

Local Institution

Shanghai, Shanxi, China

Local Institution

Tianjin, Tianjin Municipality, China

Local Institution

Beijing, , China

Local Institution

Chongqing, , China

Local Institution

Seoul, Beijing, South Korea

Local Institution

Busan, Guangdong, South Korea

Local Institution

Seoul, Guangdong, South Korea

Local Institution

Daegu, Hunan, South Korea

Local Institution

Busan, , South Korea

Local Institution

Daegu, , South Korea

Local Institution

Seoul, , South Korea

Local Institution

Seoul, , South Korea

Local Institution

Kaohsiung City, Guangdong, Taiwan

Local Institution

Tainan City, Guangdong, Taiwan

Local Institution

Kaohsiung City, , Taiwan

Local Institution

Tainan City, , Taiwan

Countries

China; South Korea; Taiwan

Related Links

http://www.bms.com/studyconnect/Pages/home.aspx

BMS clinical trial educational resource

http://www.bms.com/clinical_trials/Pages/Investigator_Inquiry_form.aspx

Investigator Inquiry form

Other Identifiers

AI447-036

Identifier Type: -

Identifier Source: org_study_id