Safety and Efficacy Study of Peginterferon Lambda-1a vs. Peginterferon Alfa-2a, Plus Ribavirin in Subjects With Genotype 1 Hepatitis C (BASIS)
This study has been completed.
Sponsor:
Bristol-Myers Squibb
Information provided by (Responsible Party):
Bristol-Myers Squibb
ClinicalTrials.gov Identifier:
NCT01754974
First received: December 19, 2012
Last updated: January 27, 2015
Last verified: December 2013
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Purpose
The purpose of this study is to determine if 48 weeks of therapy with Peginterferon Lambda plus Ribavirin is effective and safe for a treatment of chronic hepatitis C (CHC) compared to therapy with Peginterferon alfa-2a plus Ribavirin.
| Condition | Intervention | Phase |
|---|---|---|
|
Hepatitis C Virus (HCV) |
Biological: Peginterferon Lambda-1a Drug: Ribavirin Biological: Peginterferon alfa-2a |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor) Primary Purpose: Treatment |
| Official Title: | A Double-Blinded, Randomized Control Study Evaluating the Efficacy and Safety of Peginterferon Lambda-1a Compared to Peginterferon Alfa-2a, Each in Combination With Ribavirin, in the Treatment of Naive Genotype 1 Chronic Hepatitis C Subjects |
Resource links provided by NLM:
Further study details as provided by Bristol-Myers Squibb:
Primary Outcome Measures:
- Proportion of subjects who develop treatment emergent cytopenic abnormalities (anemia as defined by Hb < 10 g/dL, and/or neutropenia as defined by ANC < 750 mm3 and/or thrombocytopenia as defined by platelets < 50,000 mm3) in treatment-naive subjects [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
- ANC = Absolute Neutrophil Count
- Hb = Hemoglobin
Secondary Outcome Measures:
- Proportion of subjects with Sustained Virologic Response at Post-Treatment Follow-up Week 24 (SVR24), defined as Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) < Lower Limit of Quantitation of Assay (LLOQ) [ Time Frame: At Post-Treatment Follow-up Week 24 ] [ Designated as safety issue: No ]
- Proportion of subjects with Rapid Virologic Response (RVR) (HCV RNA not detected) [ Time Frame: On treatment Week 4 (of an up to 48-week treatment period) ] [ Designated as safety issue: No ]
- Proportion of subjects with on-treatment Serious Adverse Events (SAEs) through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects with dose reductions through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects who discontinue due to Adverse Events (AEs) through end of treatment [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
- Proportion of subjects with on-treatment Interferon (IFN)-associated symptoms as determined by adverse event reporting [ Time Frame: Up to 48 weeks of treatment ] [ Designated as safety issue: Yes ]
On-treatment IFN-associated symptoms are:
- Flu-like symptoms (as defined by pyrexia or chills or pain)
- Musculoskeletal symptoms (as defined by arthralgia or myalgia or back pain)
- Neurological symptoms (headache or dizziness)
- Constitutional symptoms (fatigue or asthenia)
- Psychiatric symptoms (depression or irritability or insomnia)
| Enrollment: | 40 |
| Study Start Date: | March 2013 |
| Study Completion Date: | September 2014 |
| Primary Completion Date: | September 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Peginterferon Lambda-1a + Ribavirin
Peginterferon Lambda-1a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
|
Biological: Peginterferon Lambda-1a
Other Name: BMS-914143
Drug: Ribavirin
Other Name: Ribasphere
|
|
Active Comparator: Peginterferon alfa-2a + Ribavirin
Peginterferon alfa-2a 180 μg solution for subcutaneous (sc) injection once weekly and Ribavirin 1000 or 1200 mg based on weight tablet by mouth twice daily for 48 weeks
|
Drug: Ribavirin
Other Name: Ribasphere
Biological: Peginterferon alfa-2a
Other Name: Pegasys
|
Eligibility| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Chronic hepatitis C, Genotype 1
- HCV RNA ≥100,000 IU/mL at screening
- Liver biopsy documenting no cirrhosis (within prior 3 years). Where approved for staging of liver disease, non-invasive imaging may be used to assess the extent of liver disease
- Naïve to prior anti-HCV therapy
Exclusion Criteria:
- Infected with HCV other than Genotype 1
- Positive Hepatitis B Surface Antigen (HBsAg), or Human Immunodeficiency Virus (HIV)-1/HIV-2 antibody at screening
- Evidence of liver disease other than HCV
- Active substance abuse
- Use of hematologic growth factors within 90 days prior to study randomization
- Evidence of history of cirrhosis based on radiologic criteria or biopsy results and clinical criteria
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754974
Please refer to this study by its ClinicalTrials.gov identifier: NCT01754974
Locations
| Czech Republic | |
| Local Institution | |
| Hradec Kralove, Czech Republic, 500 05 | |
| Local Institution | |
| Praha 4, Czech Republic, 140 00 | |
| Local Institution | |
| Usti Nad Labem, Czech Republic, 400 01 | |
| Korea, Republic of | |
| Local Institution | |
| Chungcheongnam-do, Korea, Republic of, 330-930 | |
| Local Institution | |
| Daegu, Korea, Republic of, 700-821 | |
| Local Institution | |
| Gangwon-do, Korea, Republic of, 200-704 | |
| Local Institution | |
| Gyeonggi-do, Korea, Republic of, 420-717 | |
| Local Institution | |
| Gyeonggi-do, Korea, Republic of, 463-707 | |
| Local Institution | |
| Gyeongsangnam-do, Korea, Republic of, 626-770 | |
| Local Institution | |
| Incheon, Korea, Republic of, 403-720 | |
| Local Institution | |
| Seoul, Korea, Republic of, 156-755 | |
| Mexico | |
| Local Institution | |
| Mexico, Distrito Federal, Mexico, 07760 | |
| Local Institution | |
| Mexico City, Estado De Mexico, Mexico, 06700 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44500 | |
| Local Institution | |
| Guadalajara, Jalisco, Mexico, 44650 | |
| Local Institution | |
| Distrito Federal, Mexico, 03720 | |
Sponsors and Collaborators
Bristol-Myers Squibb
Investigators
| Study Director: | Bristol-Myers Squibb | Bristol-Myers Squibb |
More Information
Additional Information:
| Responsible Party: | Bristol-Myers Squibb |
| ClinicalTrials.gov Identifier: | NCT01754974 History of Changes |
| Other Study ID Numbers: | AI452-033 2012-003508-11 |
| Study First Received: | December 19, 2012 |
| Last Updated: | January 27, 2015 |
| Health Authority: | Korea: Food and Drug Administration Brazil: National Health Surveillance Agency Brazil: Ministry of Health Brazil: National Committee of Ethics in Research Czech Republic: State Institute for Drug Control Hungary: National Institute of Pharmacy Mexico: Ministry of Health Poland: National Institute of Medicines Poland: Ministry of Health Poland: Ministry of Science and Higher Education Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products Romania: National Medicines Agency Russia: Ethics Committee Russia: Ministry of Health of the Russian Federation Russia: FSI Scientific Center of Expertise of Medical Application Turkey: Ministry of Health |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis C Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections |
Flaviviridae Infections Ribavirin Peginterferon alfa-2a Interferon-alpha Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Immunologic Factors Physiological Effects of Drugs |
ClinicalTrials.gov processed this record on September 28, 2016