Clinical Trials List
2013-01-16 - 2015-07-01
Phase III
Terminated6
ICD-10B17.10
Acute hepatitis C without hepatic coma
ICD-10B19.20
Unspecified viral hepatitis C without hepatic coma
ICD-9070.51
Hepatitis C without mention of hepatic coma, acute or unspecified
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)
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Trial Applicant
BRISTOL-MYERS SQUIBB (TAIWAN) LTD.
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Sponsor
Bristol-Myers Squibb
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Chun-Yen Lin Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Pin-Nan Cheng Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Wan-Long Chuang Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- Hsueh-Chou Lai Digestive System Department
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
- 蘇東弘 Division of General Internal Medicine
- Chun-Jen Liu Division of General Internal Medicine
- KAI-WEN HUANG Division of General Internal Medicine
- 楊宏志 Division of General Internal Medicine
- Chen-Hua Liu Division of General Internal Medicine
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
BMS-914143
PegIFN alpha
ribavavirin
telaprevir
Dosage Form
Inj.
tab
Dosage
200
375
60
Endpoints
Inclution Criteria
• Males and females, aged 18 years or older
• Patients chronically infected with HCV GT-1b as documented by positive HCV RNA and anti-HCV
antibody at screening and either:
− Positive anti-HCV antibody, HCV RNA or a positive HCV genotype test at least 6 months prior to
screening, or
− Liver biopsy or Fibroscan® (see below) consistent with chronic HCV infection (evidence of
fibrosis and/or inflammation)
• Naïve to prior treatment (IFN-, RBV- and DAA-based) or documented evidence of relapse after 48
weeks of treatment with alfa/RBV (source documentation of undetectable or < LLOQ HCV RNA at
EOT and HCV RNA ≥ LLOQ post-treatment)
• HCV RNA viral load ≥ 100,000 copies/mL at screening
• Patients with compensated cirrhosis are permitted (compensated cirrhotics are capped at approximately
10% of the treated population). If a patient does not have a documented history of cirrhosis, a liver
biopsy within three years prior to enrollment is required to demonstrate the absence of cirrhosis. If
there is a history of cirrhosis, any prior liver biopsy is sufficient. For countries where liver biopsy is
not required prior to treatment and where non-invasive 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. A Fibroscan® done prior to screening is acceptable if it was performed within
one year of screening (≥ 14.6 kPa should be considered consistent with cirrhosis)1
. If the prior
Fibroscan® was not performed within one year of screening, a new Fibroscan® is required before study
drug dosing. If a subject has both liver biopsy and Fibroscan®, the result of the liver biopsy takes
precedence over those of the Fibroscan®.
Exclusion Criteria
• Infection with HCV other than GT-1b. Mixed genotypes are not allowed
• Positive HBsAg or HIV-1/HIV-2 antibody test at screening
• Evidence of chronic liver disease caused by diseases other than chronic HCV infection (such as but not
limited to: hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease,
biliary disease, nonalcoholic hepatic steatosis and toxin exposure)
• 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
• Evidence of decompensated cirrhosis based on radiologic criteria or biopsy results and clinical criteria
• Laboratory values: hemoglobin < 12.0 g/dL (males) or < 11.0 g/dL (females), platelet count
< 90,000/mm3
, total serum bilirubin ≥ 2 mg/dL (≥ 34 µmol/L) (unless due to Gilbert’s disease)
• Any criteria that would exclude the subject from receiving Lambda, alfa-2a, DCV, RBV or TVR.
The Estimated Number of Participants
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Taiwan
32 participants
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Global
450 participants
