Hepatitis CPhase 4ELIMINATECNCT03364725
Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study
A Phase 4 study testing Glecaprevir-pibrentasvir in people with Hepatitis C and Addict Heroin, run by Id Care at 1 site in United States.
Trial summary
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants. Read more about this study
- Who is it for?
- Ages 18 to 30 years
- Conditions the study is for
- Hepatitis C, Addict Heroin
- What is being tested?
- Glecaprevir-pibrentasvir
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2018to 1 Mar 2019
- 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 18 to 30 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 - 30
- Successfully detoxed at PHBH from opioids
- Agree to participate in a closely monitored program
- Positive HCV VL > 5,000 on two tests
- Minimum one follow-up visit after discharge from PHBH to be enrolled
- Any genotype
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- APRI less than 1 and Fibrosure less than 0.45
- Negative pregnancy test in women and females must agree to acceptable contraception during treatment of HCV. Oral contraceptives that do not contain ethinyl estradiol are allowed with Mavyret
- Treatment naïve for HCV
- Signed informed consent
Who cannot join
- Cirrhosis
- Co-infection with HIV or HBV
- Inability to comply with treatment or follow up
- Renal failure with GFR less than 50 mL/min5*
- Any prior treatment for HCV
- Diabetes with HgA1c more than 8.0
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- Clinically significant abnormalities, other than HCV infection, based upon the results of a medical history, physical examination, vital signs, laboratory profile, and a 12-lead electrocardiogram (ECG) that make the subject an unsuitable candidate for this study in the opinion of the investigator, including, but not limited to:
- ALT/AST > 10x normal value,
- WBC with ANC < 1500 cell/ul,
- Hemoglobin < LLN,
- Treatment for cancer or lymphoma in the past 5 years,
- Hemoglobin A 1C > 8%.
- Any uncontrolled psychiatric, cardiac, respiratory, gastrointestinal, hematologic, neurologic, psychiatric, or other medical disease or disorder, which is unrelated to the existing HCV infection which in the opinion of the PI would prevent adherence to and participation in the trial.
- Hypersensitivity to naltrexone or polylactide-co-glycolide (PLG) microspheres
Trial locations and contacts
1 site in 1 country.
United States1 site
ID CARE
Hillsborough, New Jersey, 08844
Ronald Nahass, MD, 908-281-0221, rnahass@idcare.com
Kathleen Seneca, MSN, APN, 9082810221, kseneca@idcare.com
About this study
Official title: Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Read the detailed description
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Primary objective:
- Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old
Secondary objectives:
- Rate of sobriety maintenance for 1 year after enrollment
- Re-infection rate with HCV over 1 year after enrollment
- Re-admission rates for detox
- Cravings
- Conditions
- Hepatitis C, Addict Heroin
- Being tested
- Glecaprevir-pibrentasvir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Glecaprevir-pibrentasvirDrug
Glecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center.
| Study group | Role | What they receive |
|---|---|---|
| Open Label Treatment Arm | Experimental | Treatment arm using Glecaprevir-pibrentasvir for treatment of all patients Receives: Drug: Glecaprevir-pibrentasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cure rate of Hepatitis C Infection
Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years
Measured: 12 weeks after treatment completion viral load measure
Secondary outcomes (2)
Sobriety from Drug Use
Rate of sobriety maintenance for 1 year after enrollment
Measured: 1 year
Hepatitis C Reinfection Rate
Re-infection rate with HCV over 1 year after enrollment
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start15 Jan 2018 (estimated)
- Primary completion1 Sep 2018 (estimated)
- Study completion1 Mar 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Id Care
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie
- Responsible party
- Principal investigator, Ronald Nahass, Id Care
- Investigators
- Ronald Nahass, MD, Principal investigator, Id Care
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03364725
- Sponsor's protocol ID
- IIS # 11-507
- Acronym
- ELIMINATEC
- Status last verified
- Dec 2017
- First submitted
- 1 Dec 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Toward Elimination of Hepatitis C Virus (HCV): A Pilot Study Combining HCV and Addiction Treatment of Young Suburban Heroin Users (SHU) That Addresses Barriers to Care
- ClinicalTrials.gov ID
- NCT03364725
- Acronym / sponsor ID
- ELIMINATEC / IIS # 11-507
- Conditions
- Hepatitis C, Addict Heroin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Id CareUniversity, hospital or other
- Collaborators
- AbbVie
- Study start
- 15 Jan 2018 (estimated)
- Primary completion
- 1 Sep 2018 (estimated)
- Study completion
- 1 Mar 2019 (estimated)
- First posted
- 7 Dec 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.
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Detailed description
To demonstrate that colocation treatment of substance use disorder and Hepatitis C infection concurrently while proving addiction counselling will achieve increased duration of sobriety and elimination of Hepatitis C virus in study participants.
Primary objective:
- Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years old
Secondary objectives:
- Rate of sobriety maintenance for 1 year after enrollment
- Re-infection rate with HCV over 1 year after enrollment
- Re-admission rates for detox
- Cravings
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Open Label Treatment Arm | Experimental | Drug: Glecaprevir-pibrentasvirTreatment arm using Glecaprevir-pibrentasvir for treatment of all patients |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Age 18 - 30
- Successfully detoxed at PHBH from opioids
- Agree to participate in a closely monitored program
- Positive HCV VL > 5,000 on two tests
- Minimum one follow-up visit after discharge from PHBH to be enrolled
Key exclusion criteria (14 listed)
- Cirrhosis
- Co-infection with HIV or HBV
- Inability to comply with treatment or follow up
- Renal failure with GFR less than 50 mL/min5*
- Any prior treatment for 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 |
|---|---|---|
| Glecaprevir-pibrentasvirGlecaprevir-pibrentasvir will be dispensed to 30 patients recently detoxed off heroin in an acute detox center. | Drug | Open Label Treatment Arm |
Primary outcome
Cure rate of Hepatitis C Infection
Time frame: 12 weeks after treatment completion viral load measure
Cure rates (SVR-12, HCV plasma RNA not quantifiable 12 weeks after last dose of treatment) of HCV in 30 recently identified PWIDS under 30 years
2 secondary outcomes
Sobriety from Drug Use
Time frame: 1 year
Hepatitis C Reinfection Rate
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- 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.
Ronald Nahass, MD principal investigator
Id Care
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Glecaprevir-pibrentasvir in people with Hepatitis C and Addict Heroin, run by Id Care at 1 site in United States.
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 10 inclusion and 14 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 7 Dec 2017. 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 United States. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Ronald Nahass, MD (9082810221, rnahass@idcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cure rate of Hepatitis C Infection (time frame: 12 weeks after treatment completion viral load measure). 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 7 Dec 2017.