Hepatitis C, Chronic Clinical Trial
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.
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
| Status | Completed |
| Enrollment | 310 |
| Est. completion date | June 2014 |
| Est. primary completion date | September 2013 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years to 70 Years |
| Eligibility |
Inclusion criteria: 1. Chronic hepatitis C (HCV) genotype 1 infection 2. Chronic Human Immunodeficiency Virus (HIV) -1 infection 3. HCV treatment naive or HCV treatment experienced but only relapsers 4. Age 18 to 70 years 5. Antiretroviral treatment naive or on stable Highly Active Antiretroviral Therapy (HAART) 6. Karnofsky score >70 7. HCV viral load >1.000 IU/mL Exclusion criteria: 1. HCV infection of mixed genotype (1/2, 1/3, 1/4) 2. Evidence of acute or chronic liver due to chronic HCV infection 3. Hepatitis B virus (HBV) infection with presence of HBs-Ag 4. Active malignancy or history or malignancy within the last 5 years 5. Received concomitant systemic antiviral (other than antiretroviral), hematopoietic growth factor or immunomodulatory treatment in 28 days prior enrolment. 6. 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 7. Hemoglobin </=11g/dL for women and </= 12 g/dL for men 8. Patients with stable cardiac disease and Hemoglobin <12g/dL 9. Known hypersensitivity to any ingredient of the study drugs |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| Brazil | 1220.19.5508 Boehringer Ingelheim Investigational Site | Rio de Janeiro | |
| Brazil | 1220.19.5502 Boehringer Ingelheim Investigational Site | Rio de Janeiro - RJ | |
| Brazil | 1220.19.5506 Boehringer Ingelheim Investigational Site | Salvador | |
| Brazil | 1220.19.5503 Boehringer Ingelheim Investigational Site | Sao Paulo | |
| Brazil | 1220.19.5505 Boehringer Ingelheim Investigational Site | São Paulo | |
| Brazil | 1220.19.5501 Boehringer Ingelheim Investigational Site | São Paulo - SP | |
| France | 1220.19.3306 Boehringer Ingelheim Investigational Site | Lyon | |
| France | 1220.19.3303 Boehringer Ingelheim Investigational Site | Marseille Cedex 08 | |
| France | 1220.19.3304 Boehringer Ingelheim Investigational Site | Marseille cedex 9 | |
| France | 1220.19.3301 Boehringer Ingelheim Investigational Site | Paris | |
| France | 1220.19.3305 Boehringer Ingelheim Investigational Site | Paris | |
| France | 1220.19.3307 Boehringer Ingelheim Investigational Site | Paris Cedex 12 | |
| Germany | 1220.19.4902 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1220.19.4921 Boehringer Ingelheim Investigational Site | Berlin | |
| Germany | 1220.19.4901 Boehringer Ingelheim Investigational Site | Bonn | |
| Germany | 1220.19.4924 Boehringer Ingelheim Investigational Site | Frankfurt am Main | |
| Germany | 1220.19.4919 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1220.19.4920 Boehringer Ingelheim Investigational Site | Hamburg | |
| Germany | 1220.19.4905 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1220.19.4922 Boehringer Ingelheim Investigational Site | München | |
| Germany | 1220.19.4923 Boehringer Ingelheim Investigational Site | Würzburg | |
| Italy | 1220.19.3901 Boehringer Ingelheim Investigational Site | Antella (fi) | |
| Italy | 1220.19.3902 Boehringer Ingelheim Investigational Site | Bari | |
| Italy | 1220.19.3906 Boehringer Ingelheim Investigational Site | Brescia | |
| Italy | 1220.19.3907 Boehringer Ingelheim Investigational Site | Milano | |
| Italy | 1220.19.3905 Boehringer Ingelheim Investigational Site | Pavia | |
| Italy | 1220.19.3903 Boehringer Ingelheim Investigational Site | Roma | |
| Italy | 1220.19.3904 Boehringer Ingelheim Investigational Site | Torino | |
| Spain | 1220.19.3404 Boehringer Ingelheim Investigational Site | Badalona | |
| Spain | 1220.19.3401 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1220.19.3403 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1220.19.3409 Boehringer Ingelheim Investigational Site | Barcelona | |
| Spain | 1220.19.3402 Boehringer Ingelheim Investigational Site | L'Hospitalet de Llobregat | |
| Spain | 1220.19.3405 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1220.19.3406 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1220.19.3407 Boehringer Ingelheim Investigational Site | Madrid | |
| Spain | 1220.19.3408 Boehringer Ingelheim Investigational Site | Sevilla | |
| Switzerland | 1220.19.4101 Boehringer Ingelheim Investigational Site | Basel | |
| Switzerland | 1220.19.4103 Boehringer Ingelheim Investigational Site | Bern | |
| Switzerland | 1220.19.4102 Boehringer Ingelheim Investigational Site | Lugano | |
| Switzerland | 1220.19.4104 Boehringer Ingelheim Investigational Site | Zürich | |
| United Kingdom | 1220.19.4406 Boehringer Ingelheim Investigational Site | Brighton | |
| United Kingdom | 1220.19.4407 Boehringer Ingelheim Investigational Site | Edinburgh | |
| United Kingdom | 1220.19.4401 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1220.19.4402 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1220.19.4403 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1220.19.4404 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1220.19.4408 Boehringer Ingelheim Investigational Site | London | |
| United Kingdom | 1220.19.4405 Boehringer Ingelheim Investigational Site | Manchester | |
| United States | 1220.19.0011 Boehringer Ingelheim Investigational Site | Albany | New York |
| United States | 1220.19.0029 Boehringer Ingelheim Investigational Site | Austin | Texas |
| United States | 1220.19.0045 Boehringer Ingelheim Investigational Site | Birmingham | Alabama |
| United States | 1220.19.0008 Boehringer Ingelheim Investigational Site | Camden | New Jersey |
| United States | 1220.19.0012 Boehringer Ingelheim Investigational Site | Dallas | Texas |
| United States | 1220.19.0086 Boehringer Ingelheim Investigational Site | Fort Lauderdale | Florida |
| United States | 1220.19.0060 Boehringer Ingelheim Investigational Site | Fort Worth | Texas |
| United States | 1220.19.0027 Boehringer Ingelheim Investigational Site | Framingham | Massachusetts |
| United States | 1220.19.0009 Boehringer Ingelheim Investigational Site | Hillsborough | New Jersey |
| United States | 1220.19.0079 Boehringer Ingelheim Investigational Site | Lutherville | Maryland |
| United States | 1220.19.0006 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1220.19.0014 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1220.19.0084 Boehringer Ingelheim Investigational Site | New York | New York |
| United States | 1220.19.0044 Boehringer Ingelheim Investigational Site | Orlando | Florida |
| United States | 1220.19.0007 Boehringer Ingelheim Investigational Site | Palm Springs | California |
| United States | 1220.19.0013 Boehringer Ingelheim Investigational Site | Philadelphia | Pennsylvania |
| United States | 1220.19.0026 Boehringer Ingelheim Investigational Site | Richmond | Virginia |
| United States | 1220.19.0016 Boehringer Ingelheim Investigational Site | San Antonio | Texas |
| United States | 1220.19.0031 Boehringer Ingelheim Investigational Site | San Francisco | California |
| United States | 1220.19.0004 Boehringer Ingelheim Investigational Site | Vero Beach | Florida |
| United States | 1220.19.0005 Boehringer Ingelheim Investigational Site | Washington | District of Columbia |
| United States | 1220.19.0021 Boehringer Ingelheim Investigational Site | Winston-Salem | North Carolina |
| Lead Sponsor | Collaborator |
|---|---|
| Boehringer Ingelheim |
United States, Brazil, France, Germany, Italy, Spain, Switzerland, United Kingdom,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Sustained Virological Response (SVR12) | Percentage of participants with sustained Virological Response SVR12: Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) level <25 IU/mL, undetected 12 weeks after the planned end of treatment. | 60 weeks | No |
| Secondary | Virological Response 24 Weeks Post Treatment (SVR24) | Percentage of participants with virological response 24 weeks post treatment (SVR24): Plasma HCV RNA level<25IU/mL (undetected) 24 weeks after the planned end of treatment. | 72 weeks | No |
| Secondary | Early Treatment Success (ETS) | 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 | Week 4, week 8 and week 60 | No |
| Secondary | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment (EoT) When SVR12=Yes | The number of participants with Alanine Aminotransferase (ALT) normalisation at End of Treatment (EoT) when SVR12=yes. BL stands for baseline. | 48 weeks | No |
| Secondary | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at End of Treatment When SVR12=no | The number of participants with Alanine Aminotransferase (ALT) normalisation: ALT in normal range at End of Treatment when SVR12=no. BL stands for baseline. | 48 weeks | No |
| Secondary | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=Yes | The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=yes. BL = baseline. | 60 weeks | No |
| Secondary | The Number of Participants With Alanine Aminotransferase (ALT) Normalisation at Post Treatment When SVR12=no | The number of participants with ALT in normal range at post treatment (SVR12 Visit) when SVR12=no. BL = baseline. | 60 weeks | No |
| Secondary | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=Yes | The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=yes. BL = baseline. | 48 weeks | No |
| Secondary | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at End of Treatment When SVR12=no | The number of participants with Aspartate Aminotransferase (AST) normalisation at End of Treatment when SVR12=no. BL = baseline. | 48 weeks | No |
| Secondary | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=Yes | The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=yes. BL = baseline. | 60 weeks | No |
| Secondary | The Number of Participants With Aspartate Aminotransferase (AST) Normalisation at Post Treatment When SVR12=no | The number of participants with AST in normal range at Post Treatment (SVR12 Visit) when SVR12=no. BL = baseline. | 60 weeks | No |
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