Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
NCT ID: NCT02897596
Last Updated: 2019-02-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
62 participants
INTERVENTIONAL
2017-04-28
2019-10-30
Brief Summary
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Detailed Description
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Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Genotype 1b
Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks.
Grazoprevir 100 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Elbasvir 50 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Genotype 1a and 4
Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks.
Grazoprevir 100 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Elbasvir 50 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
Interventions
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Grazoprevir 100 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Elbasvir 50 mg/d 8 weeks
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Grazoprevir 100 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Elbasvir 50 mg/d 12 weeks
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Patients with early chronic hepatitis C (Genotype 1 or 4) which is defined as chronic hepatitis C with known episode of AHC within the last 4 years including those who failed to PEG/RBV or those who never received therapy for AHC. AHC infection is diagnosed on the basis of documented HCV-RNA positivity (\> 10.000 IU/mL) and anti-HCV seroconversion.
* No history of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
* Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result \<8 kPa
* Be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
* Be on stable HIV Antiretroviral Therapy (ART) for at least 8 weeks prior to study entry using a dual NRTI backbone of tenofovir or abacavir
Exclusion Criteria
* Patients with chronic hepatitis C genotypes other than 1 or 4.
* History of ascites, bleeding esophageal varices, hepatic encephalopathy, or other signs/symptoms of advanced liver disease
* Have liver disease staging assessment as follows: Fibroscan performed within 3 previous months of Day 1 of this study showing result \> 8kPa
* Not be HIV-1 infected, documented by any licensed rapid HIV test and confirmed by a licensed Western blot or a second antibody test by a method other than the initial rapid HIV and/or E/CIA, or by HIV-1 p24 antigen, or plasma HIV-1 RNA viral load.
* Due to known or suspected drug-drug interactions, for the purpose of this study, the use of Non Nucleoside Reverse Transcriptase Inhibitors, Inhibitors or Protease Inhibitors against HIV will be not allow.
18 Years
ALL
No
Sponsors
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Fundacion Clinic per a la Recerca Biomédica
OTHER
Responsible Party
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Anna Cruceta
Project manager
Locations
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Hospital Clínico y provincial de Barcelona
Barcelona, , Spain
Countries
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Other Identifiers
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EARLY-HEP-C
Identifier Type: -
Identifier Source: org_study_id
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