Efficacy and Safety of BI 201335 (Faldaprevir) in Combination With Pegylated Interferon-alpha and Ribavirin in Treatment-Experienced Genotype 1 Hepatitis C Infected Patients (STARTverso 3)
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| ClinicalTrials.gov Identifier: NCT01358864 |
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Recruitment Status :
Completed
First Posted : May 24, 2011
Results First Posted : October 28, 2015
Last Update Posted : August 29, 2016
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Sponsor:
Boehringer Ingelheim
Information provided by (Responsible Party):
Boehringer Ingelheim
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Brief Summary:
The aim of this trial is to evaluate the efficacy and the safety of BI 201335 given for 12 or 24 weeks in combination with PegIFN/RBV given for 48 weeks as compared to PegIFN/RBV alone in chronic GT-1 hepatitis C virus infected patients who failed a prior PegIFN/RBV treatment.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Hepatitis C, Chronic | Drug: BI 201335 Drug: Pegylated Interferon-alpha (IFN) Drug: Ribavirin (RBV) Drug: Placebo | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 678 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Phase III, Randomised, Double-blind and Placebo Controlled Study of Once Daily BI 201335, 240 mg for 12 or 24 Weeks in Combination With Pegylated interferon-a (PegIFNa) and Ribavirin (RBV) in Patients With Genotype 1 Chronic Hepatitis C Infection Who Failed a Prior PegIFN/RBV Treatment |
| Study Start Date : | June 2011 |
| Actual Primary Completion Date : | February 2013 |
| Actual Study Completion Date : | May 2014 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Placebo/PegIFN/RBV
patient to receive two capsules identical to those containing BI201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
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Drug: Pegylated Interferon-alpha (IFN)
Pegylated Interferon-alpha for 48 weeks Drug: Ribavirin (RBV) Ribavirin (RBV) for 24 or 48 weeks Drug: Placebo Placebo to BI201335 for 24 weeks |
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Experimental: BI201335 12 weeks
patient to receive two capsules containing BI 201335 once a day for 12 weeks and PegIFN/RBV for 48 weeks
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Drug: BI 201335
BI 201335 once a day (QD) for 24 weeks Drug: Pegylated Interferon-alpha (IFN) Pegylated Interferon-alpha for 48 weeks Drug: Ribavirin (RBV) Ribavirin (RBV) for 24 or 48 weeks |
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Experimental: BI201335 24 weeks
patient to receive two capsules containing BI 201335 once a day for 24 weeks and PegIFN/RBV for 48 weeks
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Drug: BI 201335
BI 201335 once a day (QD) for 24 weeks Drug: Pegylated Interferon-alpha (IFN) Pegylated Interferon-alpha for 48 weeks Drug: Ribavirin (RBV) Ribavirin (RBV) for 24 or 48 weeks |
Primary Outcome Measures :
- Sustained Virological Response 12 Weeks Post Treatment (SVR12) [ Time Frame: 12 weeks post treatment, up to 60 weeks ]Percentage of participants with sustained virological response (SVR12) 12 weeks post treatment defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 12 weeks after the originally planned treatment duration.
Secondary Outcome Measures :
- Virological Response After 24 Weeks of Treatment Discontinuation (SVR24) [ Time Frame: 24 weeks post treatment, up to 72 weeks ]Percentage of participants with virological response after 24 weeks of treatment discontinuation (SVR24) defined as plasma Hepatitis C virus Ribonucleic acid (HCV RNA) level <25 IU/mL (undetected) 24 weeks after the originally planned treatment duration.
- Early Treatment Success (ETS) [ Time Frame: Week 4 and Week 8 ]Percentage of participants with early Treatment Success (ETS) defined as a plasma HCV RNA level <25 IU/mL (undetected or detected) at Week 4 and <25 IU/mL (undetected) at Week 8.
- ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ]The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment (EoT) when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
- ALT Normalisation: ALT in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ]The number of participants with alanine aminotransferase (ALT) in normal range at the end of treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
- AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=NO [ Time Frame: End of treatment, up to 48 weeks ]The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
- AST Normalisation: AST in Normal Range at End of Treatment, When SVR12=YES [ Time Frame: End of treatment, up to 48 weeks ]The number of participants with aspartate aminotransferase (AST) in normal range at the end of treatment (EoT) when patients have sustained virological response 12 weeks post treatment. BL=baseline
- ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ]The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
- ALT Normalisation: ALT in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ]The number of participants with alanine aminotransferase (ALT) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
- AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, When SVR12=NO [ Time Frame: 12 weeks post treatment, up to 60 weeks ]The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients do not have sustained virological response 12 weeks post treatment. BL=baseline
- AST Normalisation: AST in Normal Range 12 Weeks Post Treatment, SVR12=YES [ Time Frame: 12 weeks post treatment, up to 60 weeks ]The number of participants with aspartate aminotransferase (AST) in normal range post treatment when patients have sustained virological response 12 weeks post treatment. BL=baseline
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| Ages Eligible for Study: | 18 Years to 70 Years (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Chronic hepatitis C genotype 1 infection, diagnosed at least 6 months prior to screening
- Confirmed prior virological failure with an approved dose of PegIFN/RBV
- Age 18 to 70 years,
- HCV RNA (RiboNucleic Acid) = 1,000 IU/mL at screening,
Exclusion criteria:
- HCV infection of mixed genotype; Hepatitis B Virus (HBV) or Human Immunodeficiency Virus (HIV) co-infection
- Evidence of acute or chronic liver disease due to causes other than chronic HCV infection,
- Decompensated liver disease, or history of decompensated liver disease,
- Body weight < 40 or > 125 kg,
- Clinical evidence of significant or unstable cardiovascular disease, chronic pulmonary disease, history or evidence of retinopathy or clinically significant ophthalmological disorder
- Pre-existing psychiatric condition that could interfere with the subject's participation in and completion of the study
- Laboratory parameters disorders (thalassemia major, sickle cell anemia or G6PD deficit)
- Hemoglobin < 12 g/dL for women and < 13 g/dL for men
- Patients who have been previously treated with at least one dose of any antiviral or immunomodulatory drug other than interferon alfa or ribavirin for acute or chronic HCV infection including and not restricted to protease or polymerase inhibitors,
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): NCT01358864
Locations
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Sponsors and Collaborators
Boehringer Ingelheim
Investigators
| Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim |
Additional Information:
| Responsible Party: | Boehringer Ingelheim |
| ClinicalTrials.gov Identifier: | NCT01358864 |
| Other Study ID Numbers: |
1220.7 2010-021715-17 ( EudraCT Number: EudraCT ) |
| First Posted: | May 24, 2011 Key Record Dates |
| Results First Posted: | October 28, 2015 |
| Last Update Posted: | August 29, 2016 |
| Last Verified: | July 2016 |
Additional relevant MeSH terms:
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Hepatitis A Hepatitis C Hepatitis C, Chronic Hepatitis Liver Diseases Digestive System Diseases Hepatitis, Viral, Human Virus Diseases Infections Enterovirus Infections Picornaviridae Infections RNA Virus Infections Blood-Borne Infections |
Communicable Diseases Flaviviridae Infections Hepatitis, Chronic Interferons Ribavirin Interferon-alpha Antineoplastic Agents Antiviral Agents Anti-Infective Agents Antimetabolites Molecular Mechanisms of Pharmacological Action Immunologic Factors Physiological Effects of Drugs |