Phase III Trial of BI 201335 (Faldaprevir) in Treatment Naive (TN) and Relapser Hepatitis C Virus (HCV)-Human Inmunodeficiency Virus (HIV) Coinfected Patients (STARTverso 4)
This study is ongoing, but not recruiting participants.
Sponsor:
Boehringer Ingelheim Pharmaceuticals
Information provided by (Responsible Party):
Boehringer Ingelheim Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01399619
First received: July 20, 2011
Last updated: February 6, 2013
Last verified: February 2013
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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 24-48 weeks, according to re-randomisation of Early Treatment Success (ETS) patients at 24 weeks to stop PegIFN/RBV or continue PegIFN/RBV until week 48. If no ETS, then PegIFN/RB for 48 weeks, in HCV treatment-naive or relapsers patients coinfected with HIV
Condition | Intervention | Phase |
---|---|---|
Hepatitis C, Chronic |
Drug: PegIFN/RBV Drug: BI201335 Drug: BI201335 24W Drug: Bi 201335 |
Phase 3 |
Study Type: | Interventional |
Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
Official Title: | Safety and Efficacy of 120mg and 240mg BI 201335 Once Daily in Combination With Pegylated Interferon Alpha and Ribavirin for Treatment of Chronic Hepatitis C (HCV) Genotype 1 Infection in HIV/HCV Co-infected Patients. A Multinational, Randomised, Parallel Group, Open-label Trial. |
Resource links provided by NLM:
Further study details as provided by Boehringer Ingelheim Pharmaceuticals:
Primary Outcome Measures:
- Sustained Virological Response (SVR): Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment. [ Time Frame: 60 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment. [ Time Frame: 72 weeks ] [ Designated as safety issue: No ]
- Early Treatment Success (ETS): Plasma HCV RNA level<25 IU/mL (detected or undetected) at Week 4 and HCV RNA< 25 IU/mL, undetected at Week 8 [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]
- Alanine Aminotransferase (ALT) and Aspartate Aminotransferase (AST) normalisation: ALT and AST in normal range at end of treatment and post-treatment [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]
Estimated Enrollment: | 306 |
Study Start Date: | September 2011 |
Estimated Study Completion Date: | November 2014 |
Estimated Primary Completion Date: | February 2013 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
Experimental: BI201335 12W
patient to receive two capsules of BI 201335 once a day for 12 weeks and pegIFN/RBV for 24 or 48 weeks
|
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: BI201335
BI201335 for 12w
|
Experimental: BI 201335 24W
patient to receive two capsules of BI 201335 once a day for 24 weeks and PegIFN/RBV for 24 or 48 weeks
|
Drug: BI201335 24W
BI201335 for 24w
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
|
Experimental: BI 201335 24 W
patient to receive one capsule of BI 201335 once a day for 24 weeks and pegIFN/RBV for 24 or 48 weeks
|
Drug: PegIFN/RBV
PegIFN/RBV for 24 or 48w
Drug: Bi 201335
BI 201335 for 24 w
|
![](https://webarchive.library.unt.edu/web/20130305100617im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years to 70 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Criteria
Inclusion criteria:
- Chronic hepatitis C (HCV) genotype 1 infection
- Chronic Human Immunodeficiency Virus (HIV) -1 infection
- HCV treatment naive or HCV treatment experienced but only relapsers
- Age 18 to 70 years
- Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART)
- Karnofsky score >70
- HCV viral load >1.000 IU/mL
Exclusion criteria:
- HCV infection of mixed genotype (1/2, 1/3, 1/4)
- Evidence of acute or chronic liver due to chronic HCV infection
- Hepatitis B virus (HBV) infection with presence of HBs-Ag
- Active malignancy or history or malignancy within the last 5 years
- Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment.
- Decompensated liver disease,as evidenced by ascites, hepatic encephalopathy, esophageal variceal bleeding, and/or laboratory values that add up to >/= 7 points according tho the Child-Turcotte-Pugh classification
- Hemoglobin </=11g/dL for women and </= 12 g/dL for men
- Patients with stable cardiac disease and Hemoglobin <12g/dL
- Known hypersensitivity to any ingredient of the study drugs
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01399619
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Sponsors and Collaborators
Boehringer Ingelheim Pharmaceuticals
Investigators
Study Chair: | Boehringer Ingelheim | Boehringer Ingelheim Pharmaceuticals |
![](https://webarchive.library.unt.edu/web/20130305100617im_/http://clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Boehringer Ingelheim Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT01399619 History of Changes |
Other Study ID Numbers: | 1220.19, 2010-021734-59 |
Study First Received: | July 20, 2011 |
Last Updated: | February 6, 2013 |
Health Authority: | Brazil: Ministry of Health France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis) Germany: Federal Institute for Drugs and Medical Devices Italy: Ethics Committee Spain: Spanish Agency of Medicines Switzerland: Swissmedic United Kingdom: Medicines and Healthcare Products Regulatory Agency United States: Food and Drug Administration |
Additional relevant MeSH terms:
Hepatitis Hepatitis A Hepatitis C Hepatitis C, Chronic Liver Diseases Digestive System Diseases Hepatitis, Viral, Human |
Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Flaviviridae Infections Hepatitis, Chronic |
ClinicalTrials.gov processed this record on March 03, 2013