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

NCT01995266 | Completed Phase 3 Results

• 1 other identifier: AI447-036
• Study Type: interventional
• Target: 218
• Locations: 3 countries
• Sites: 38

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

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24)

  SVR was defined as Hepatitis C Virus ribonucleic acid (HCV RNA) \< lower limit of quantitation (LLOQ) target detected (TD) or not detected (TND) at post-treatment follow-up Week 24.

  24 Weeks after treatment discontinuation (Follow-up Week 24)

Secondary Outcomes (9)

• Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12)

  12 Weeks after treatment discontinuation (Follow-up Week 12)

• Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation

  7 days after treatment discontinuation

• Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24

  24 Weeks after treatment discontinuation (Follow-up Week 24)

• Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24)

  Week 24 (End-of Treatment)

• Number of Participants With Rapid Virologic Response (RVR)

  Treatment Week 4

Study Arms (1)

Asunaprevir + Daclatasvir

EXPERIMENTAL

Asunaprevir 100mg soft capsule by mouth twice daily for 24 weeks and Daclatasvir 60mg tablet by mouth once daily for 24 weeks

Drug: Asunaprevir; Drug: Daclatasvir

Interventions

Asunaprevir DRUG

Also known as: BMS-650032

Asunaprevir + Daclatasvir

Daclatasvir DRUG

Also known as: BMS-790052

Asunaprevir + Daclatasvir

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Positive anti-HCV antibody, HCV RNA or positive HCV genotype test at least 6 months prior to screening
• 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:
• 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
• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bristol-Myers Squibb: lead

Study Sites (38)

Local Institution

Beijing, Beijing Municipality, 100015, China

Location

Local Institution

Beijing, Beijing Municipality, 100034, China

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Beijing, Beijing Municipality, 100050, China

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Beijing, Beijing Municipality, 100054, China

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Beijing, Guangdong, 100039, China

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Chongqing, Guangdong, 400038, China

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Guangzhou, Guangdong, 510060, China

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Guangzhou, Guangdong, 510515, China

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Guangzhou, Guangdong, 510630, China

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Wuhan, Hubei, 430022, China

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Changsha, Hunan, 410008, China

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Changsha, Hunan, 410011, China

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Nanjing, Jiangsu, 210002, China

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Nanjing, Jiangsu, 210003, China

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Nanjing, Jiangsu, 210029, China

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Changchun, Jilin, 130021, China

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Shenyang, Liaoning, 110000, China

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Xi'an, Shan3xi, 710038, China

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Xi'an, Shan3xi, 710061, China

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Shanghai, Shanghai Municipality, 200025, China

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Shanghai, Shanghai Municipality, 200235, China

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Beijing, Shanxi, 710038, China

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Shanghai, Shanxi, 710061, China

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Tianjin, Tianjin Municipality, 300192, China

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Beijing, 100039, China

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Chongqing, 400038, China

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Seoul, Beijing, 140-743, South Korea

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Busan, Guangdong, 602-715, South Korea

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Seoul, Guangdong, 137-701, South Korea

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Daegu, Hunan, 700-712, South Korea

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Busan, 602-715, South Korea

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Daegu, 700-712, South Korea

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Seoul, 137-701, South Korea

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Seoul, 140-743, South Korea

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Kaohsiung City, Guangdong, 807, Taiwan

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Tainan, Guangdong, 736, Taiwan

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Local Institution

Kaohsiung City, 807, Taiwan

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Local Institution

Tainan, 736, Taiwan

Location

Related Links

• BMS clinical trial educational resource
• Investigator Inquiry form

MeSH Terms

Conditions

Hepatitis C

Interventions

asunaprevir; daclatasvir

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Bristol-Myers Squibb Study Director
• Organization: Bristol-Myers Squibb

clinical.trials@bms.com

Please email

Study Officials

• Bristol-Myers Squibb

  Bristol-Myers Squibb

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 21, 2013
• First Posted: November 26, 2013
• Study Start: February 28, 2014
• Primary Completion: July 31, 2015
• Study Completion: July 31, 2015
• Last Updated: August 11, 2020
• Results First Posted: July 11, 2019

Record last verified: 2020-08

Locations

CN (26); KR (8); TW (4)