Chronic Hepatitis CPhase 4NCT05895448
Treatment of HCV-Infected Recent Injection Drug Users in U.S. Liver Clinics
A Phase 4 study testing velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . in people with Chronic Hepatitis C and People Who Inject Drugs, run by Center For Hepatitis C, Atlanta, GA at 1 site in United States.
Trial summary
Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis C, People Who Inject Drugs
- What is being tested?
- velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Mar 2018to 1 Jan 2024
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic HCV infection and PWID arm: use of intravenous drug use at least once in preceding six months. In Non-PWID arm: no use of intravenous drug use at least once in preceding six months.
Who cannot join
- Co-infection with chronic hepatitis B; Decompensated cirrhosis current or by history; inability to sign informed consent; unwilling to take therapy or unable to obtain therapy
Trial locations and contacts
1 site in 1 country.
United States1 site
Wellstar Atlanta Medical Center
Atlanta, Georgia, 30312
About this study
Official title: Treatment of Recent Injection Drug Use With Chronic HCV Infection in U.S. Liver Referral Clinics: A Prospective, Observational Cohort Study And Contemporaneous Therapy Cohort Without Injection Drug Use
Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded.
Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.
Read the detailed description
Chronically HCV-infected participants were recruited and treated at two liver referral clinics in Georgia, but had been referred from opioid substitution therapy clinics, primary care and GI clinics, neighboring hospitals, and correctional centers. Once consented, a nurse navigator was assigned to each participant was responsible for all subjects' appointments, and med supplies. Drug testing was mandated at specified intervals. Patients with recent injection drug use (within 6 months) were assigned to the PWID (people who inject drugs) arm, and those who hadn't injected within 6 months, but agreed to be in the study and signed consents, were assigned to the non-PWID arm. Both groups were treated with velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic). Adherence was assessed by pill counts. Mandatory treatment visits were scheduled for baseline, 4 and 12 weeks (+/- 2 weeks) and follow-up (FU) week 12 (+ 4 months). Long-term FU was flexible and could be virtual, but was mandated once yearly with HCV RNA testing.
- Conditions
- Chronic Hepatitis C, People Who Inject Drugs
- Being tested
- velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .Drug
Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily
| Study group | Role | What they receive |
|---|---|---|
| PWID (people who inject drugs) | Experimental | velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had used intravenous drugs at least once in preceding six months. Receives: Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . |
| Non-PWID | Active comparator | velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had NOT used intravenous drugs at least once in preceding six months, but were treated concurrently in the same hepatology referral clinics. Receives: Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained Virologic Response
Undetectable HCV RNA 12 weeks after completion of antiviral therapy
Measured: 24 weeks after medication initiation
Secondary outcomes (3)
Reinfection rate hepatitis C
Detection of HCV RNA in follow-up period after SVR has been obtained
Measured: in follow-up period (expected 2-3 years)
Intravenous drug use
rate of IV drug use compared between baseline and end of follow-up
Measured: informed consent through end of follow-up (up to 3 years)
Opioid Substitution Therapy (OST)
rate of OST compared between baseline and end of follow-up
Measured: informed consent through end of follow-up (up to 3 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2023
- Study start1 Mar 2018
- Primary completion1 Nov 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- PWID arm and non-PWID arm prospective, parallel observational cohorts
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Center For Hepatitis C, Atlanta, GA
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- brian pearlman, MD, Principal investigator, Wellstar Internal Medicine Associates
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05895448
- Sponsor's protocol ID
- 1364-2018
- Status last verified
- May 2023
- First submitted
- 31 May 2023
- Last updated
- 8 Jun 2023
- 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 8 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Recent Injection Drug Use With Chronic HCV Infection in U.S. Liver Referral Clinics: A Prospective, Observational Cohort Study And Contemporaneous Therapy Cohort Without Injection Drug Use
- ClinicalTrials.gov ID
- NCT05895448
- Acronym / sponsor ID
- 1364-2018
- Conditions
- Chronic Hepatitis C, People Who Inject Drugs
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Center For Hepatitis C, Atlanta, GAUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 1 Nov 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 8 Jun 2023 (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.
Direct antiviral therapy (standard of care) administered to chronic hepatitis C-infected patients, in two hepatology clinics, who had used intravenous drugs in the past 6 months of signing informed consent (IC). This cohort was compared to concurrently treated chronic hepatitis C patients who were not intravenous drug users, who signed IC in these same clinics. Follow-up expected two years after cure and relapse rates recorded.
Primary end point was SVR rate and secondary end points included reinfection rates in follow-up period.
Detailed description
Chronically HCV-infected participants were recruited and treated at two liver referral clinics in Georgia, but had been referred from opioid substitution therapy clinics, primary care and GI clinics, neighboring hospitals, and correctional centers. Once consented, a nurse navigator was assigned to each participant was responsible for all subjects' appointments, and med supplies. Drug testing was mandated at specified intervals. Patients with recent injection drug use (within 6 months) were assigned to the PWID (people who inject drugs) arm, and those who hadn't injected within 6 months, but agreed to be in the study and signed consents, were assigned to the non-PWID arm. Both groups were treated with velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic). Adherence was assessed by pill counts. Mandatory treatment visits were scheduled for baseline, 4 and 12 weeks (+/- 2 weeks) and follow-up (FU) week 12 (+ 4 months). Long-term FU was flexible and could be virtual, but was mandated once yearly with HCV RNA testing.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- PWID arm and non-PWID arm prospective, parallel observational cohorts
| Arm | Type | Receives |
|---|---|---|
| PWID (people who inject drugs) | Experimental | Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had used intravenous drugs at least once in preceding six months. |
| Non-PWID | Active comparator | Drug: velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .velpatasvir (100 mg) and sofosbuvir (400 mg) once daily for 12 weeks (brand or branded generic) in subjects who had NOT used intravenous drugs at least once in preceding six months, but were treated concurrently in the same hepatology referral clinics. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Chronic HCV infection and PWID arm: use of intravenous drug use at least once in preceding six months. In Non-PWID arm: no use of intravenous drug use at least once in preceding six months.
Key exclusion criteria (1 listed)
- Co-infection with chronic hepatitis B; Decompensated cirrhosis current or by history; inability to sign informed consent; unwilling to take therapy or unable to obtain therapy
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 |
|---|---|---|
| velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) .Directly active antiviral therapy (velpatasvir 100 mg+sofobuvir 400 mg) once daily | Drug | Non-PWID, PWID (people who inject drugs) |
Primary outcome
Sustained Virologic Response
Time frame: 24 weeks after medication initiation
Undetectable HCV RNA 12 weeks after completion of antiviral therapy
3 secondary outcomes
Reinfection rate hepatitis C
Time frame: in follow-up period (expected 2-3 years)
Intravenous drug use
Time frame: informed consent through end of follow-up (up to 3 years)
Opioid Substitution Therapy (OST)
Time frame: informed consent through end of follow-up (up to 3 years)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2023.
- 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.
brian pearlman, MD principal investigator
Wellstar Internal Medicine Associates
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 velpatasvir and sofosbuvir once daily for 12 weeks (brand or branded generic) . in people with Chronic Hepatitis C and People Who Inject Drugs, run by Center For Hepatitis C, Atlanta, GA 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 1 inclusion and 1 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 8 Jun 2023. 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?
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 Virologic Response (time frame: 24 weeks after medication initiation). 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 2023.