Hepatitis CPhase 3EARLY-HEP-CNCT02897596
Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
A Phase 3 study testing Grazoprevir 100 mg/d 8 weeks, Elbasvir 50 mg/d 8 weeks and Grazoprevir 100 mg/d 12 weeks in people with Hepatitis C and HIV, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, HIV
- What is being tested?
- Grazoprevir 100 mg/d 8 weeks, Elbasvir 50 mg/d 8 weeks and Grazoprevir 100 mg/d 12 weeks
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 62 participants
- Where
- 1 siteSpain
- Study dates
- 28 Apr 2017to 30 Oct 2019
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ≥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
Who cannot join
- < 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the detailed description
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir
Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
- Conditions
- Hepatitis C, HIV
- Being tested
- Grazoprevir 100 mg/d 8 weeks, Elbasvir 50 mg/d 8 weeks, Grazoprevir 100 mg/d 12 weeks, Elbasvir 50 mg/d 12 weeks
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Grazoprevir 100 mg/d 8 weeksDrug
Also called MK-5172 100 mg
Patients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks.
Elbasvir 50 mg/d 8 weeksDrug
Also called MK-8742 50 mg
Patients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks.
Grazoprevir 100 mg/d 12 weeksDrug
Also called MK-5172 100 mg
Patients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks.
Elbasvir 50 mg/d 12 weeksDrug
Also called MK-8742 50 mg
Patients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Genotype 1b | Experimental | Grazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks. Receives: Drug: Grazoprevir 100 mg/d 8 weeks; Drug: Elbasvir 50 mg/d 8 weeks |
| Genotype 1a and 4 | Experimental | Grazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks. Receives: Drug: Grazoprevir 100 mg/d 12 weeks; Drug: Elbasvir 50 mg/d 12 weeks |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virological response.
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
Measured: 24 weeks
Secondary outcomes (3)
Reinfection rate
Evaluate the reinfection rate during 1 year of follow-up Sustained virological response defined as HCV-RNA undetectable at post-treatment.
Measured: 1 year
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.
Measured: 2 years
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.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2016 (estimated)
- Study start28 Apr 2017
- Primary completion28 Apr 2019 (estimated)
- Study completion30 Oct 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 62 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion Clinic per a la Recerca Biomédica
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anna Cruceta, Fundacion Clinic per a la Recerca Biomédica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02897596
- Sponsor's protocol ID
- EARLY-HEP-C
- Acronym
- EARLY-HEP-C
- Status last verified
- Feb 2019
- First submitted
- 22 Aug 2016
- Last updated
- 15 Feb 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of GZR/EBR in Early Chronic Hepatitis C in HIV/HCV Co-infected Patients
- ClinicalTrials.gov ID
- NCT02897596
- Acronym / sponsor ID
- EARLY-HEP-C / EARLY-HEP-C
- Conditions
- Hepatitis C, HIV
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 62 participants (estimated)
- Lead sponsor
- Fundacion Clinic per a la Recerca BiomédicaUniversity, hospital or other
- Study start
- 28 Apr 2017 (actual)
- Primary completion
- 28 Apr 2019 (estimated)
- Study completion
- 30 Oct 2019 (estimated)
- First posted
- 13 Sep 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Genotype 1b: 8 weeks treatment with Grazoprevir/Elbasvir
Genotype 1a and 4: 12 weeks treatment with Grazoprevir/Elbasvir
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genotype 1b | Experimental | Drug: Grazoprevir 100 mg/d 8 weeks, Drug: Elbasvir 50 mg/d 8 weeksGrazoprevir 100 mg/d during 8 weeks. Elbasvir 50 mg/d during 8 weeks. |
| Genotype 1a and 4 | Experimental | Drug: Grazoprevir 100 mg/d 12 weeks, Drug: Elbasvir 50 mg/d 12 weeksGrazoprevir 100 mg/d during 12 weeks. Elbasvir 50 mg/d during 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- ≥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.
Key exclusion criteria (6 listed)
- < 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Grazoprevir 100 mg/d 8 weeksAlso: MK-5172 100 mgPatients with 1b HCV genotype will be received treatment with Grazoprevir (100 mg) during 8 weeks. | Drug | Genotype 1b |
| Elbasvir 50 mg/d 8 weeksAlso: MK-8742 50 mgPatients with 1b HCV genotype will be received treatment with Elbasvir (50mg) during 8 weeks. | Drug | Genotype 1b |
| Grazoprevir 100 mg/d 12 weeksAlso: MK-5172 100 mgPatients with 1a or 4 HCV genotype will be received treatment with Grazoprevir (100 mg) during 12 weeks. | Drug | Genotype 1a and 4 |
| Elbasvir 50 mg/d 12 weeksAlso: MK-8742 50 mgPatients with 1a or 4 HCV genotype will be received treatment with Elbasvir (50mg) during 12 weeks. | Drug | Genotype 1a and 4 |
Primary outcome
Sustained virological response.
Time frame: 24 weeks
Sustained virological response 12 (SVR12) defined as HCV-RNA undetectable at post-treatment.
3 secondary outcomes
Reinfection rate
Time frame: 1 year
Evaluate the safety and tolerability by means of number of participants with treatment-related adverse events.
Time frame: 2 years
Evaluate the emergence of of viral resistance-associated variants (RAV) resistant to MK-5172 and MK-8742. during the follow up.
Time frame: 2 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Grazoprevir 100 mg/d 8 weeks, Elbasvir 50 mg/d 8 weeks and Grazoprevir 100 mg/d 12 weeks in people with Hepatitis C and HIV, run by Fundacion Clinic per a la Recerca Biomédica at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Sustained virological response. (time frame: 24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.