HCVPhase 4C-RESCUENCT03105349
A Clinical Trial of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotypes 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A
A Phase 4 study testing elbasvir/grazoprevir, Sofosbuvir and Ribavirin in people with HCV, run by Fundacion SEIMC-GESIDA at 5 sites in Spain.
Trial summary
This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- HCV
- What is being tested?
- elbasvir/grazoprevir, Sofosbuvir and Ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 5 sitesSpain
- Study dates
- 1 Jul 2017to Feb 2018
- Phase
- Phase 4
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above
- HCV RNA plasma concentration of at least 1000 IU / mL
- Subjects previously treated with NS5A-based regimens for at least 8 weeks.
- Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of therapy of A5 based on NS5A against HCV.
- Subjects with compensated hepatic cirrhosis (Child A) could be included.
- For patients with HIV coinfection:
- Be infected with HIV-1, documented by any rapid HIV test with the corresponding license and confirmed by a Western blot or second antibody test using a method other than the initial rapid HIV and / or I / CIA method or by HIV-1 p24 antigen or viral load of HIV-1 RNA plasma.
- Be on stable HIV antiretroviral therapy (ART) for at least 4 weeks prior to entry into the study using a dual ITN backbone of tenofovir or abacavir and emtricitabine or lamivudine PLUS raltegravir or dolutegravir or rilpivirine (with CD4 + T cell count> 100 cells / mm 3 and undetectable HIV-1 RNA at baseline. Results from prior analysis will be accepted within 24 weeks prior to study entry).
Who cannot join
- Subjects with hepatitis other than C or steatosis.
- Subjects previously treated less than 8 weeks with regimens based on NS5A.
- Evidence of previous hepatocellular carcinoma although it has criteria of cure
- Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
- Subjects suspected of clinical or genotypic reinfection of HCV.
- Subject with HCV response regrowth while receiving NS5A-based ADA therapy against HCV. Said regrowth is defined as a confirmation of detectable HCV RNA after achieving undetectable HCV RNA during NS5A-based AADs against HCV.
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- Recent history of drug or alcohol abuse.
- Important comorbidities.
- Pregnant, lactating or non-lactating women Contraceptives, if they are women of childbearing age. Women of childbearing age are defined as those women who have not undergone permanent infertility procedures or who have been amenorrheic for less than 12 months.
- Subjects with a glomerular filtration rate of less than 30 ml / min.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
Spain5 sites
Hospital Univ. La Paz
Madrid, Madri, 28046
Hospital Univ. Gregorio Marañon
Madrid, 28007
Hospital Infanta Leonor
Madrid, 28031
Hospita 12 de octubre
Madrid, 28041
Hospital Univ. La Paz
Madrid, 28046
About this study
Official title: A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A
This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A
Read the detailed description
The duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (Week 12 post treatment and week 24 post treatment) The study in an open label study with a single arm .
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbasvir/grazoprevirDrug
Also called Zepatier
16 weeks treatment
SofosbuvirDrug
16 weeks treatment
RibavirinDrug
16 weeks treatment
| Study group | Role | What they receive |
|---|---|---|
| Single arm | Experimental | 16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina Receives: Drug: elbasvir/grazoprevir; Drug: Sofosbuvir; Drug: Ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
The rate of patients achieved SVR12
Measured: Week 12 post treatment
Secondary outcomes (13)
The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12.
To analyze the impact of VARs NS5A/NS3 on RVS12
Measured: Week 12 post treatment
The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12.
Analyze the impact of VARs NS5A/NS3 on RVS12
Measured: Week 12 post treatment
The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12.
Analyze the impact of VARs NS5A/NS3 on RVS12
Measured: Week 12 post treatment
The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24.
Analyze the impact of VARs NS5A/NS3 on RVS24
Measured: Week 24 post treatment
The occurrence of Viral resistance variants (VARs) to NS5A or elbasvir, to NS3 or grazoprevir and to NS5B or SOF in patients who did not reach SVR12 after 16 weeks of re-treatment
the occurrence of resistance in patients who did not reach SVR12 after 16 weeks of re-treatment
Measured: Week 16
The occurrence of resistance variants (VARs) viral to NS5A or elbasvir, to NS3 or grazoprevir, and to NS5B or SOF in HIV patients included
The impact of VARs NS5A/NS3 on RVS12
The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them.
Measured: Week 12 post treatment
The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them
the impact of treatment with EL / BRA plus SOFT and ribavirin in HIV-1 subjects
Measured: Week 4, week 8, week 12 and week 16
The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period.
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with at least one adverse experience
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience related to medication
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a severe adverse experience
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a serious adverse experience related to medication
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience leading to disruption
Adverse events
Measured: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Apr 2017
- Study start1 Jul 2017 (estimated)
- Primary completionDec 2017 (estimated)
- Study completionFeb 2018 (estimated)
Why it stopped: No availability of investigational medication.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HCVStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacion SEIMC-GESIDA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03105349
- Sponsor's protocol ID
- GESIDA 9516
- Acronym
- C-RESCUE
- Status last verified
- Jun 2018
- First submitted
- 16 Mar 2017
- Last updated
- 8 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Open Label, Multicentric Clinical Trial of a Single Arm of 16 Weeks of Duration to Evaluate Retreatment With Elbasvir/Grazoprevir Plus Sofosbuvir and Ribavirin in Patients With Chronic Hepatitis C Genotype 1,4 Who Have Failed to Treat With a Regime Based on an Inhibitor of the NS5A
- ClinicalTrials.gov ID
- NCT03105349
- Acronym / sponsor ID
- C-RESCUE / GESIDA 9516
- Conditions
- HCV
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No availability of investigational medication.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Fundacion SEIMC-GESIDAUniversity, hospital or other
- Study start
- 1 Jul 2017 (estimated)
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 7 Apr 2017 (actual)
- 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.
This is a phase 4 clinical trial to treat patients who have failed to treat with regimen based on an inhibitor of the NS5A
Detailed description
The duration of the treatment will be 16 weeks and then will be a security perid with 2 visits (Week 12 post treatment and week 24 post treatment) The study in an open label study with a single arm .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single arm | Experimental | Drug: elbasvir/grazoprevir, Drug: Sofosbuvir, Drug: Ribavirin16 weeks treatment with elbasvir/grazoprevir plus sofosbuvir and ribavirina |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Adults with chronic HCV genotype 1, 4 infection with or without HIV infection aged 18 years or above
- HCV RNA plasma concentration of at least 1000 IU / mL
- Subjects previously treated with NS5A-based regimens for at least 8 weeks.
- Patients with HCV relapse after receiving a complete treatment with NS5A-based AAD regimen for at least 8 weeks and becoming undetectable at the end of treatment. Relapse is defined as a confirmed HCV RNA detectable upon completion of therapy of A5 based on NS5A against HCV.
- Subjects with compensated hepatic cirrhosis (Child A) could be included.
Key exclusion criteria (10 listed)
- Subjects with hepatitis other than C or steatosis.
- Subjects previously treated less than 8 weeks with regimens based on NS5A.
- Evidence of previous hepatocellular carcinoma although it has criteria of cure
- Subjects with past or current decompensated liver disease; Only decompensated patients who have received a liver transplant and have not decompensated after transplantation will be included.
- Subjects suspected of clinical or genotypic reinfection of HCV.
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 |
|---|---|---|
| elbasvir/grazoprevirAlso: Zepatier16 weeks treatment | Drug | Single arm |
| Sofosbuvir16 weeks treatment | Drug | Single arm |
| Ribavirin16 weeks treatment | Drug | Single arm |
Primary outcome
The rate of patients achieved SVR12
Time frame: Week 12 post treatment
13 secondary outcomes
The proportion of subjects infected with HCV genotype 1a with reference VARs NS5A / NS3 who achieved RVS12.
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotype 1b with reference VARs NS5A / NS3 who achieved RVS12.
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotype 4 with reference VARs NS5A /NS3 who achieved RVS12.
Time frame: Week 12 post treatment
The proportion of subjects infected with HCV genotypes 1.4 with reference VARs NS5A /NS3 who achieved RVS24.
Time frame: Week 24 post treatment
The occurrence of Viral resistance variants (VARs) to NS5A or elbasvir, to NS3 or grazoprevir and to NS5B or SOF in patients who did not reach SVR12 after 16 weeks of re-treatment
Time frame: Week 16
The occurrence of resistance variants (VARs) viral to NS5A or elbasvir, to NS3 or grazoprevir, and to NS5B or SOF in HIV patients included
Time frame: Week 12 post treatment
The proportion of subjects developing HIV-1 virological failure (HIV RNA> 200 Copies / mL), confirmed in 2 consecutive tests with at least 2 weeks between them
Time frame: Week 4, week 8, week 12 and week 16
The proportion of subjects experiencing adverse events of high laboratory values who report as ECI at any time during the study period.
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with at least one adverse experience
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience related to medication
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a severe adverse experience
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with a serious adverse experience related to medication
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
The proportion of subjects with an adverse experience leading to disruption
Time frame: Week 4, week 8, week 12, week 16, week 12 post-treatment and week 24 post-treatment
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2018.
- Individual participant dataSharing planned: No
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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.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing elbasvir/grazoprevir, Sofosbuvir and Ribavirin in people with HCV, run by Fundacion SEIMC-GESIDA at 5 sites 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 8 inclusion and 10 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: withdrawn, as of the sponsor's last update on 8 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
The rate of patients achieved SVR12 (time frame: Week 12 post treatment). 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 8 Jun 2018.