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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01995266
Recruitment Status : Completed
First Posted : November 26, 2013
Results First Posted : July 11, 2019
Last Update Posted : July 11, 2019
Sponsor:
Information provided by (Responsible Party):
Bristol-Myers Squibb

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

Condition or disease Intervention/treatment Phase
Hepatitis C Drug: Asunaprevir Drug: Daclatasvir Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 218 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 3, Open-Label Study With Daclatasvir And Asunaprevir (DUAL) for Subjects With Genotype 1b Chronic Hepatitis C (HCV) Infection Who Are Intolerant or Ineligible to Interferon Alfa Therapies With or Without Ribavirin
Actual Study Start Date : February 28, 2014
Actual Primary Completion Date : July 31, 2015
Actual Study Completion Date : July 31, 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Daclatasvir

Arm Intervention/treatment
Experimental: Asunaprevir + Daclatasvir

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

Daclatasvir 60mg tablet by mouth once daily for 24 weeks

Drug: Asunaprevir
Other Name: BMS-650032

Drug: Daclatasvir
Other Name: BMS-790052




Primary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 24 (SVR24) [ Time Frame: 24 Weeks after treatment discontinuation (Follow-up Week 24) ]
    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.


Secondary Outcome Measures :
  1. Percentage of Participants With Sustained Virologic Response (SVR) at Post-Treatment Follow-up Week 12 (SVR12) [ Time Frame: 12 Weeks after treatment discontinuation (Follow-up Week 12) ]
    SVR12 was defined as HCV RNA < LLOQ target detected or not detected at post-treatment follow-up Week 12. For SVR12, missing HCV RNA data at follow-up Week 12 was imputed using the Next Value Carried Backwards (NVCB) approach.

  2. Number of Participants With Adverse Events (AEs), Serious AEs (SAEs), Death, and AEs Leading to Discontinuation [ Time Frame: 7 days after treatment discontinuation ]
    An AE is any untoward medical occurrence in a participant who received study drug without regard to possibility of causal relationship. An AE can therefore be any unfavorable and unintended sign (example, a clinically significant abnormal laboratory finding), symptom, or disease temporally associated with the use of a drug, whether or not it is considered related to the drug. An SAE is an AE resulting in any of the following outcomes or deemed significant for any other reason: death, initial or prolonged inpatient hospitalization, life-threatening experience (immediate risk of dying), persistent or significant disability/incapacity, or a congenital anomaly, or a medically important event.

  3. Percentage of Participants With SVR24 by the rs12979860 Single Nucleotide Polymorphisms (SNP) in the IL 28B Gene at Post-Treatment Follow-up Week 24 [ Time Frame: 24 Weeks after treatment discontinuation (Follow-up Week 24) ]
    Participants categorized into three genotypes based on SNPs in the IL28B gene were assessed for SVR24, defined as response in which hepatitis C virus RNA levels below lower limit of quantitation or below target detected or target not detected at follow-up Week 24.

  4. Percentage of Participants With HCV RNA< LLOQ Target Not Detected at the End of Treatment (Week 24) [ Time Frame: Week 24 (End-of Treatment) ]
    Blood was drawn from each participant to assess HCV RNA plasma levels using the Roche COBAS® Taqman quantitative RT-PCR assay, v2.0. The lower and upper limits of quantitation (LOQs) of the assay for HCV GT-1 were 25 IU/mL and 3.91 X10^8 IU/mL, respectively; the limit of detection was ~ 10 IU/mL

  5. Number of Participants With Rapid Virologic Response (RVR) [ Time Frame: Treatment Week 4 ]
    RVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 4.

  6. Percentage of Participants With Complete Early Virologic Response (cEVR) [ Time Frame: Treatment Week 12 ]
    cEVR was defined as HCV RNA < LLOQ, target not detected at treatment Week 12.

  7. Number of Participants With Extended Rapid Virologic Response (eRVR) [ Time Frame: Treatment Week 4 and Week 12 ]
    eRVR was defined as HCV RNA < LLOQ, target not detected at treatment Weeks 4 and 12.

  8. Number of Participants With HCV RNA < LLOQ Target Detected or Not Detected at the End of Treatment (Week 24) [ Time Frame: Week 24 (End-of Treatment) ]
    Antiviral efficacy is measured by the number of participants with HCV RNA< LLOQ (lower limit of quantification), TD (target detected) or TND (target not detected) at End of Treatment (Week 24)

  9. Number of Participants With Virologic Response (VR) at Treatment Week 4 and 12 [ Time Frame: Treatment Week 4 and 12 ]
    VR was defined as HCV RNA < LLOQ, target detected or not detected at specific time points (Week 4 and Week 12)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01995266


Locations
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China, Beijing
Local Institution
Beijing, Beijing, China, 100015
Local Institution
Beijing, Beijing, China, 100034
Local Institution
Beijing, Beijing, China, 100050
Local Institution
Beijing, Beijing, China, 100054
China, Guangdong
Local Institution
Beijing, Guangdong, China, 100039
Local Institution
Chongqing, Guangdong, China, 400038
Local Institution
Guangzhou, Guangdong, China, 510060
Local Institution
Guangzhou, Guangdong, China, 510515
Local Institution
Guangzhou, Guangdong, China, 510630
China, Hubei
Local Institution
Wuhan, Hubei, China, 430022
China, Hunan
Local Institution
Changsha, Hunan, China, 410008
Local Institution
Changsha, Hunan, China, 410011
China, Jiangsu
Local Institution
Nanjing, Jiangsu, China, 210002
Local Institution
Nanjing, Jiangsu, China, 210003
Local Institution
Nanjing, Jiangsu, China, 210029
China, Jilin
Local Institution
Changchun, Jilin, China, 130021
China, Liaoning
Local Institution
Shenyang, Liaoning, China, 110000
China, Shan3xi
Local Institution
Xi'an, Shan3xi, China, 710038
Local Institution
Xi'an, Shan3xi, China, 710061
China, Shanghai
Local Institution
Shanghai, Shanghai, China, 200025
Local Institution
Shanghai, Shanghai, China, 200235
China, Shanxi
Local Institution
Beijing, Shanxi, China, 710038
Local Institution
Shanghai, Shanxi, China, 710061
China, Tianjin
Local Institution
Tianjin, Tianjin, China, 300192
China
Local Institution
Beijing, China, 100039
Local Institution
Chongqing, China, 400038
Korea, Republic of
Local Institution
Seoul, Beijing, Korea, Republic of, 140-743
Local Institution
Busan, Guangdong, Korea, Republic of, 602-715
Local Institution
Seoul, Guangdong, Korea, Republic of, 137-701
Local Institution
Daegu, Hunan, Korea, Republic of, 700-712
Local Institution
Busan, Korea, Republic of, 602-715
Local Institution
Daegu, Korea, Republic of, 700-712
Local Institution
Seoul, Korea, Republic of, 137-701
Local Institution
Seoul, Korea, Republic of, 140-743
Taiwan
Local Institution
Kaohsiung, Guangdong, Taiwan, 807
Local Institution
Tainan, Guangdong, Taiwan, 736
Local Institution
Kaohsiung, Taiwan, 807
Local Institution
Tainan, Taiwan, 736
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
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Study Director: Bristol-Myers Squibb Bristol-Myers Squibb
Additional Information:
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Responsible Party: Bristol-Myers Squibb
ClinicalTrials.gov Identifier: NCT01995266    
Other Study ID Numbers: AI447-036
First Posted: November 26, 2013    Key Record Dates
Results First Posted: July 11, 2019
Last Update Posted: July 11, 2019
Last Verified: July 2019
Additional relevant MeSH terms:
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Hepatitis C
Hepatitis
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
RNA Virus Infections
Flaviviridae Infections
Asunaprevir
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action