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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT02897596
Other study ID # EARLY-HEP-C
Secondary ID
Status Active, not recruiting
Phase Phase 3
First received
Last updated
Start date April 28, 2017
Est. completion date October 30, 2019

Study information

Verified date February 2019
Source Fundacion Clinic per a la Recerca Biomédica
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

Evaluate the efficacy of 12 or 8 weeks treatment with Grazoprevir/Elbasvir in Early Chronic Hepatitis C GT1,4 in HIV co-infected patients and evaluate the safety and tolerability of Grazoprevir + Elbasvir in HIV-HCV co-infected patients.


Description:

Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir

Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 62
Est. completion date October 30, 2019
Est. primary completion date April 28, 2019
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria:

- =18 years of age

- 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:

- < 18 years of age

- 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.

Study Design


Intervention

Drug:
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.

Locations

Country Name City State
Spain Hospital Clínico y provincial de Barcelona Barcelona

Sponsors (1)

Lead Sponsor Collaborator
Fundacion Clinic per a la Recerca Biomédica

Country where clinical trial is conducted

Spain, 

Outcome

Type Measure Description Time frame Safety issue
Primary Sustained virological response. Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment. 24 weeks
Secondary Reinfection rate Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment. 1 year
Secondary Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events. number of adverse events treatment-related assess in 62 patients. 2 years
Secondary Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up. In case of viral failure confirmation during the follow up, viral resistence-associated variants will be assess by samples genotyping HCV protease and NS5A gene at baseline and after the viral failure. 2 years
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