Hepatitis C, ChronicPhase 4NCT03057847
Sofosbuvir/Velpatasvir in Postpartum Women With Opioid Use Disorder and Chronic Hepatitis C Infection
A Phase 4 study testing Sofosbuvir/Velpatasvir in people with Hepatitis C, Chronic and Opioid-use Disorder, run by Elizabeth Krans, MD at 1 site in United States.
Trial summary
Incorporating Hepatitis C Virus (HCV) treatment into opioid maintenance treatment program clinical protocols is an innovative health care delivery model that has been associated with improved HCV treatment uptake in non-pregnant, drug-using populations. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hepatitis C, Chronic, Opioid-use Disorder
- What is being tested?
- Sofosbuvir/Velpatasvir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2018to 24 Feb 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Able and willing to provide written informed consent to be screened for and take part in the study procedures
- Able and willing to provide adequate contact information
- Chronic Hepatitis C Virus (HCV), genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV ribonucleic acid (RNA) viral load at screening
- Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
- Documented negative Hepatitis B testing within 3 months prior to enrollment
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- Negative human immunodeficiency virus (HIV) testing within 3 months prior to enrollment
- Per participant report at screening and enrollment, agrees not to participate in other research studies involving drugs or medical devices for the duration of study participation
- Plans to deliver at Magee-Womens Hospital of University of Pittsburgh Medical Center (UPMC)
Who cannot join
- Participant report of any of the following at Screening or Enrollment:
- Previous treatment for Hepatitis C virus with a sofosbuvir based regimen
- Use of any medications contraindicated with concurrent use of sofosbuvir/velpatasvir according to the EPCLUSA package insert
- Plans to relocate away from the study site area in the next 18 months
- Current sexual partner is known to be infected with HIV or Hepatitis B virus
- History of decompensated cirrhosis (history of variceal bleed, ascites or hepatic encephalopathy)
Show all 17Show fewer
- Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
- Ongoing illicit drug use evidenced by positive urine drug screen with appropriate confirmatory testing for anything other than marijuana since the first prenatal visit that cannot be explained by a prescribed medication
- Breastfeeding or pumping and feeding infant breastmilk
- At screening or enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)
- Has any of the following laboratory abnormalities at Screening:
- Aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than 10 times the upper limited of normal
- Hemoglobin less than 10 g/dL
- Platelet count less than 90,000 per mm3
- International normalized ratio (INR) > 1.5
- Glomerular filtration rate (GFR) < 40
- Has any other condition that, in the opinion of the IoR/designee, would preclude informed consent, make study participation unsafe, complicate interpretation of study outcome data, or otherwise interfere with achieving study objectives.
Trial locations and contacts
1 site in 1 country.
United States1 site
Magee Womens Hospital of UPMC
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Management of Hepatitis C Virus (HCV) Infection in Pregnant Women With Opioid Use Disorder (OUD): the Potential of an Integrated Medical Home Model: Phase IV Trial of Sofosbuvir/Velpatasvir (SOF/VEL) in Postpartum Women With Chronic HCV
Incorporating Hepatitis C Virus (HCV) treatment into opioid maintenance treatment program clinical protocols is an innovative health care delivery model that has been associated with improved HCV treatment uptake in non-pregnant, drug-using populations. This "medical home" approach would combine HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into one comprehensive clinical care model. The purpose of this study is to evaluate the feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment program on adherence to HCV treatment regimens and evaluate the rate of intravenous drug use (IVDU) recidivism, HCV reinfection and health related Quality of Life (QOL) in women with opioid use disorder (OUD) during the first postpartum year.
The protocol involves three separate study phases. All 3 study phases will occur with support from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum. Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8 and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months after treatment completion. Treatment effectiveness and sustained virologic response (SVR) will be evaluated at 3 months and rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment completion.
- Conditions
- Hepatitis C, Chronic, Opioid-use Disorder
- Being tested
- Sofosbuvir/Velpatasvir
- Medical subject headings
- Hepatitis C, Chronic, Opioid-Related Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sofosbuvir/VelpatasvirDrug
Also called Epclusa
Sofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period
| Study group | Role | What they receive |
|---|---|---|
| SOF/VEL | Experimental | Sofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period Receives: Drug: Sofosbuvir/Velpatasvir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Number of participants initiating HCV treatment
Measured: Delivery to 10 months postpartum
Secondary outcomes (6)
Intravenous Drug Use Recidivism
Rate of intravenous drug use recidivism by participant self-report and Urine Drug Screening
Measured: 15 months post-treatment, up to 18 months
HCV Reinfection
Count of participants 15 months post-treatment with Hepatitis C Virus reinfection as measured by related lab tests
Measured: 15 months post-treatment
Health-related Quality of Life
Health-related quality of life using Promise 57 scale
Measured: 15 months post-treatment
Number of Participants Achieving Sustained Virologic Response (SVR)
Number of participants with non-detectable Hepatitis C Virus (HCV) Ribonucleic acid (RNA) post-treatment as measured by SVR testing
Measured: End of treatment (12 weeks postpartum) up to 18 months
Number of Participants Reporting Treatment Side Effects
Number of participants reporting treatment side effects using standardized list
Measured: End of treatment (12 weeks postpartum)
Number of Missed Treatment Doses
Treatment adherence assessed by missed treatment doses
Measured: End of treatment (12 weeks postpartum)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2017
- Study start30 Jan 2018
- Primary completion24 Feb 2022
- Study completion24 Feb 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Hepatitis C, ChronicStudies 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
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single arm, open-label, prospective cohort study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elizabeth Krans, MD
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Elizabeth Krans, MD, University of Pittsburgh
- Investigators
- Elizabeth E Krans, MD, MSc, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03057847
- Sponsor's protocol ID
- STUDY19030088
- Status last verified
- Apr 2023
- First submitted
- 10 Feb 2017
- Last updated
- 6 May 2023
- Results posted
- Yes, on ClinicalTrials.gov
- 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 6 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Management of Hepatitis C Virus (HCV) Infection in Pregnant Women With Opioid Use Disorder (OUD): the Potential of an Integrated Medical Home Model: Phase IV Trial of Sofosbuvir/Velpatasvir (SOF/VEL) in Postpartum Women With Chronic HCV
- ClinicalTrials.gov ID
- NCT03057847
- Acronym / sponsor ID
- STUDY19030088
- Conditions
- Hepatitis C, Chronic, Opioid-use Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Elizabeth Krans, MDUniversity, hospital or other
- Study start
- 30 Jan 2018 (actual)
- Primary completion
- 24 Feb 2022 (actual)
- Study completion
- 24 Feb 2022 (actual)
- First posted
- 20 Feb 2017 (actual)
- Results
- Posted 6 May 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Incorporating Hepatitis C Virus (HCV) treatment into opioid maintenance treatment program clinical protocols is an innovative health care delivery model that has been associated with improved HCV treatment uptake in non-pregnant, drug-using populations. This "medical home" approach would combine HCV and opioid maintenance treatment into one treatment regimen and incorporate the expertise of obstetricians, hepatologists, substance abuse treatment providers and pediatricians into one comprehensive clinical care model. The purpose of this study is to evaluate the feasibility/acceptability of a combined, peripartum HCV and opioid maintenance treatment program on adherence to HCV treatment regimens and evaluate the rate of intravenous drug use (IVDU) recidivism, HCV reinfection and health related Quality of Life (QOL) in women with opioid use disorder (OUD) during the first postpartum year.
The protocol involves three separate study phases. All 3 study phases will occur with support from hepatology providers at Magee-Womens Hospital. Phase 1 involves screening, enrollment and a baseline assessment of liver function, HCV infection (genotype, viral load) and blood and urine studies in HCV-infected patients during pregnancy. In Phase 2, subjects will undergo 12 weeks of sofosbuvir/velpatasvir therapy initiated at 2 weeks postpartum. Feasibility/acceptability and adherence to sofosbuvir/velpatasvir will be assessed at 4, 8 and 12 weeks of therapy. In Phase 3, subjects will continue to be followed for 15 months after treatment completion. Treatment effectiveness and sustained virologic response (SVR) will be evaluated at 3 months and rates of IVDU recidivism, HCV reinfection and patient centered outcomes such as health related quality of life (QOL) will be assessed at 6, 9 and 12 months following treatment completion.
Study design
- Primary purpose
- Health services research
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single arm, open-label, prospective cohort study
| Arm | Type | Receives |
|---|---|---|
| SOF/VEL | Experimental | Drug: Sofosbuvir/VelpatasvirSofosbuvir/Velpatasvir, One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Age 18 or older
- Able and willing to provide written informed consent to be screened for and take part in the study procedures
- Able and willing to provide adequate contact information
- Chronic Hepatitis C Virus (HCV), genotype 1 (1a, 1b), 2 (2a, 2b), 3, 4, 5, 6 infection, defined as a HCV antibody and detectable HCV ribonucleic acid (RNA) viral load at screening
- Pregnancy at 28 + 0 to 37 + 6 weeks' gestation at enrollment with gestational dating confirmed by ultrasound
Key exclusion criteria (17 listed)
- Participant report of any of the following at Screening or Enrollment:
- Reports participating in any other research study involving drugs or medical devices within 60 days or less prior to enrollment
- Ongoing illicit drug use evidenced by positive urine drug screen with appropriate confirmatory testing for anything other than marijuana since the first prenatal visit that cannot be explained by a prescribed medication
- Breastfeeding or pumping and feeding infant breastmilk
- At screening or enrollment, as determined by the Protocol Chair, any significant uncontrolled active or chronic cardiovascular, renal, liver, hematologic, neurologic, gastrointestinal, psychiatric, endocrine, respiratory, immunologic disorder or infectious disease (other than Hepatitis C)
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 |
|---|---|---|
| Sofosbuvir/VelpatasvirAlso: EpclusaSofosbuvir/Velpatasvir One tablet (400 mg of sofosbuvir and 100 mg of velpatasvir) taken orally once daily for 12 weeks in the postpartum period | Drug | SOF/VEL |
Primary outcome
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment
Time frame: Delivery to 10 months postpartum
Number of participants initiating HCV treatment
6 secondary outcomes
Intravenous Drug Use Recidivism
Time frame: 15 months post-treatment, up to 18 months
HCV Reinfection
Time frame: 15 months post-treatment
Health-related Quality of Life
Time frame: 15 months post-treatment
Number of Participants Achieving Sustained Virologic Response (SVR)
Time frame: End of treatment (12 weeks postpartum) up to 18 months
Number of Participants Reporting Treatment Side Effects
Time frame: End of treatment (12 weeks postpartum)
Number of Missed Treatment Doses
Time frame: End of treatment (12 weeks postpartum)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Elizabeth E Krans, MD, MSc principal investigator
University of Pittsburgh
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 Sofosbuvir/Velpatasvir in people with Hepatitis C, Chronic and Opioid-use Disorder, run by Elizabeth Krans, MD 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 9 inclusion and 17 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: finished, as of the sponsor's last update on 6 May 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?
Yes. Results are posted in the registry (first posted 6 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Participants Initiating in Hepatitis C Virus (HCV) Treatment (time frame: Delivery to 10 months postpartum). 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 6 May 2023.