Hepatitis CPhase 4NCT03093415
Hepatitis C Treatment in PWIDs: MAT or Syringe Exchange Assisted-therapy vs Standard of Care
A Phase 4 study testing elbasvir-grazoprevir (50 mg/100 mg) in people with Hepatitis C and Substance Use Disorders, run by Oregon Health and Science University at 2 sites in United States.
Trial summary
hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given the complexity of older pegylated interferon containing regimens, formerly the standard of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hepatitis C, Substance Use Disorders, Substance Abuse, Intravenous
- What is being tested?
- elbasvir-grazoprevir (50 mg/100 mg)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 2 sitesUnited States
- Study dates
- 30 May 2017to 6 Jun 2019
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Genotype 1b and genotype 1a without baseline NS5A resistance or Genotype 4
- APRI Score <0.7; if >0.7 a Fibrosure/Fibrotest or Fibroscan score of F2 or less
- No clinical or laboratory evidence of cirrhosis
- Readiness for treatment based on ability to make >2/3 sequential office visits
- Patients must be assessed to have decision-making capacity, be capable of consenting, and not be displaying evidence of overt intoxication.
Who cannot join
- Clinical or Laboratory Evidence of Cirrhosis
- Elevated prothrombin time unrelated to anticoagulation, hemoglobin level less than 12.3 g/L in females and <14 g/L in males, platelet count <150 × 109 cells/L), white blood cells (WBC) <4.0 x103/mm3 , aminotransferase levels more than 10 times the upper limit of normal, or albumin level <3.5 g/L.
- Previous treatment for hepatitis C infection
- Hepatocellular carcinoma
- HIV or hepatitis B virus co-infection
- Subjects taking medications that are contra-indicated to administer with Zepatier including phenytoin, carbamazepine, rifampin, St. John's Wort, and cyclosporine AND unable to change these medications to one without interactions.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Old Town Clinic
Portland, Oregon, 97214
Outside In
Portland, Oregon, 97214
About this study
Official title: A Prospective Cohort Study Comparing the Effectiveness of Zepatier for the Treatment of Hepatitis C in an Academic Center Population to People Who Inject Drugs (PWIDs) in a Safety Net Clinic Setting Engaged in Either a Medication Assisted Therapy (MAT) or Syringe Exchange Program
hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given the complexity of older pegylated interferon containing regimens, formerly the standard of care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite their relative simplicity, creating a bottleneck of human resources necessary to fight the largest infectious epidemic in North America. In addition, stigma and fear over cost has lead payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of new infections occur in this population.
This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs in a real world, community health clinic setting.
Read more
There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory medication assisted therapy with buprenorphine or extended released injectable naltrexone. Cohort two maintains active injection drug use with needle exchange and risk reduction education.
These groups are compared to a 50 patient retrospective cohort of people with substance use disorders at tertiary care hepatology-based treatment program.
All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.
The investigators hypothesize there is no difference in sustained viremic response at 12 or 48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community health clinic setting as compared to the standard-of-care subspecialty setting.
Read the detailed description
Hepatitis C has traditionally been treated in subspecialty health centers given the complexity of older pegylated interferon containing regimens, formerly the standard of care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite their relative simplicity, creating a bottleneck of human resources necessary to fight the largest infectious epidemic in North America. In addition, stigma and fear over cost has lead payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of new infections occur in this population.
This study evaluates the effectiveness of treatment of hepatitis C virus (HCV) with elbasvir-grasoprevir in people who inject drugs (PWIDs) in a real world, community health clinic setting.
There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory medication assisted therapy with buprenorphine or extended released injectable naltrexone. Cohort two maintains active injection drug use with needle exchange and risk reduction education.
These groups are compared to a 50 patient retrospective cohort of people with substance use disorders at tertiary care hepatology-based Academic Health Center.
All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks. The investigators exclude patients who: are under the age of 18; have a history of liver transplant; have failed past treatment of HCV; have an Aspartate aminotransferase Platelet Ratio Index (APRI) > 0.7 or APRI >0.7 but fibrosure/fibroscan of F2 or less; patients with genotype 1a and Nonstructural 5a (NS5a) resistance associated variants (RAVs); have clinical or radiologic evidence of cirrhosis; have aminotransferase levels >10x upper limit of normal; have a hemoglobin of less than 11g/dL, and are co-infected with hepatitis B or HIV.
The investigators hypothesize there is no difference in sustained viremic response at 12 or 48 weeks post-completion treatment (SVR 12, 48) when treating patients with a DAA in a community health clinic setting as compared to the standard-of-care subspecialty setting.
- Being tested
- elbasvir-grazoprevir (50 mg/100 mg)
- Keywords
- Hepatitis C, HCV, People Who Inject Drugs, PWID, Medication Assisted Therapy, MAT, Needle Exchange Program
- Medical subject headings
- Hepatitis C, Substance-Related Disorders, Substance Abuse, Intravenous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
elbasvir-grazoprevir (50 mg/100 mg)Drug
Also called Zepatier
12 week treatment of elbasvir-grazoprevir (50 mg/100 mg)
| Study group | Role | What they receive |
|---|---|---|
| Old Town Clinic, Medication Assisted Therapy group | Active comparator | 25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. Receives: Drug: elbasvir-grazoprevir (50 mg/100 mg) |
| Outside In Clinic, Needle Exchange Program | Active comparator | 25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. Receives: Drug: elbasvir-grazoprevir (50 mg/100 mg) |
| OHSU Hepatology Clinic, Academic center Retrospective Cohort | Other | 50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. Receives: Drug: elbasvir-grazoprevir (50 mg/100 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR 12
Sustained Viremic Response at 12 weeks post-completion of treatment. SVR12 was determined negative if undetectable (<20 copies) by polymerase chain reaction and positive if EITHER loss-to-follow up and no lab data or virus was detected greater than 20 copies.
Measured: 24 weeks post-initiation of treatment (12 weeks post-completion of treatment)
Secondary outcomes (5)
SVR 48
Sustained Viremic Response at 48 weeks post-completion of treatment (SVR48). Participants "Achieving SVR48" had a negative hepatitis C real time polymerase chain reaction (RT-PCR) test at 48 weeks after end of treatment. Participants who "Did Not Achieve SVR48" had a positive hepatitis C RT-PCR test at 48 weeks after end of treatment.
Measured: 60 weeks post-initiation of treatment (48 weeks post-completion of treatment)
Discontinuation Rate or Lost To Follow Up
Percentage of patients discontinuing medications prior to completion of 12 weeks or being lost to follow up, defined as inability to reach patient after 3 attempts and patients not following up with primary endpoint labs (SVR 12, 48)
Measured: Study duration (60 weeks)
NS5A Resistance
Percentage of patients with genotype 1a and NS5A Resistance-Associated Variants (RAVs)
Measured: At Study Screening/Enrollment
Medication Adherence
Adherence determined by client/subject self-reported medication adherence measured by percentage of pills taken on a monthly basis. Categorically separated into < 90% adherence, 90-99% adherence, 100% adherence.
Measured: 12 weeks (duration of treatment)
Injection Drug Use Relapse (IDU)
Self reported relapse IDU following HCV treatment (MAT arm)
Measured: Duration of study (60 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Mar 2017
- Study start30 May 2017
- Primary completion6 Jun 2019
- Study completion6 Jun 2019
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.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Hepatitis CStudies of the same condition, open and under way.
- More trials run by Oregon Health and Science UniversityThe sponsor's other registered studies.
- 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
- Two parallel investigational groups in different community health clinic treatment settings assigned to treatment with elbasvir-grazoprevir as compared to an academic hepatology clinic retrospective cohort treated with elbasvir-grazoprevir.
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oregon Health and Science University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Andrew Seaman, Oregon Health and Science University
- Investigators
- Atif Zaman, MD, Principal investigator, Oregon Health and Science University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03093415
- Sponsor's protocol ID
- CRS00002743
- Status last verified
- Oct 2020
- First submitted
- 9 Mar 2017
- Last updated
- 12 Nov 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All electronic data will be maintained encrypted in the Red Cap repository. Only the primary investigator and co-investigator will have access to the master spreadsheet linking study and personal identifiers. Andrew Seaman, co-investigator and primary study contact, will be listed as the repository guardian. He will be responsible for ensuring data are released according to OHSU policy and the institutional review board (IRB) approved repository protocol, executing a repository sharing agreement in case data are released for future research, ensuring the security and confidentiality of all stored data, ensuring the security and confidentiality of data, and tracking releases of data. The repository guardian will be responsible for verifying that future releases are done in concordance with pre-proposed limits and the original consent. Data transport at the time of any future IRB approved data sharing will be approved by an updated research services agreement and separate IRB approval.
Publications
Islam MM, Topp L, Conigrave KM, White A, Reid SE, Grummett S, Haber PS, Day CA. Linkage into specialist hepatitis C treatment services of injecting drug users attending a needle syringe program-based primary healthcare centre. J Subst Abuse Treat. 2012 Dec;43(4):440-5. doi: 10.1016/j.jsat.2012.07.007. Epub 2012 Aug 29.
PubMed 22938915Bruggmann P, Litwin AH. Models of care for the management of hepatitis C virus among people who inject drugs: one size does not fit all. Clin Infect Dis. 2013 Aug;57 Suppl 2(Suppl 2):S56-61. doi: 10.1093/cid/cit271.
PubMed 23884067Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, Goldberg DJ, Hellard ME. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013 Aug;57 Suppl 2:S80-9. doi: 10.1093/cid/cit306.
PubMed 23884071Sylvestre DL, Litwin AH, Clements BJ, Gourevitch MN. The impact of barriers to hepatitis C virus treatment in recovering heroin users maintained on methadone. J Subst Abuse Treat. 2005 Oct;29(3):159-65. doi: 10.1016/j.jsat.2005.06.002.
PubMed 16183464Grebely J, Knight E, Genoway KA, Viljoen M, Khara M, Elliott D, Gallagher L, Storms M, Raffa JD, DeVlaming S, Duncan F, Conway B. Optimizing assessment and treatment for hepatitis C virus infection in illicit drug users: a novel model incorporating multidisciplinary care and peer support. Eur J Gastroenterol Hepatol. 2010 Mar;22(3):270-7. doi: 10.1097/meg.0b013e32832a8c4c.
PubMed 20425880Newman AI, Beckstead S, Beking D, Finch S, Knorr T, Lynch C, MacKenzie M, Mayer D, Melles B, Shore R. Treatment of chronic hepatitis C infection among current and former injection drug users within a multidisciplinary treatment model at a community health centre. Can J Gastroenterol. 2013 Apr;27(4):217-23. doi: 10.1155/2013/515636.
PubMed 23616960Mason K, Dodd Z, Sockalingam S, Altenberg J, Meaney C, Millson P, Powis J. Beyond viral response: A prospective evaluation of a community-based, multi-disciplinary, peer-driven model of HCV treatment and support. Int J Drug Policy. 2015 Oct;26(10):1007-13. doi: 10.1016/j.drugpo.2015.04.012. Epub 2015 Apr 29.
PubMed 26005037
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Cohort Study Comparing the Effectiveness of Zepatier for the Treatment of Hepatitis C in an Academic Center Population to People Who Inject Drugs (PWIDs) in a Safety Net Clinic Setting Engaged in Either a Medication Assisted Therapy (MAT) or Syringe Exchange Program
- ClinicalTrials.gov ID
- NCT03093415
- Acronym / sponsor ID
- CRS00002743
- Keywords
- Hepatitis C, HCV, People Who Inject Drugs, PWID, Medication Assisted Therapy, MAT, Needle Exchange Program
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oregon Health and Science UniversityUniversity, hospital or other
- Study start
- 30 May 2017 (actual)
- Primary completion
- 6 Jun 2019 (actual)
- Study completion
- 6 Jun 2019 (actual)
- First posted
- 28 Mar 2017 (actual)
- Results
- Posted 12 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
hepatitis C virus (HCV) has traditionally been treated in subspecialty health centers given the complexity of older pegylated interferon containing regimens, formerly the standard of care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite their relative simplicity, creating a bottleneck of human resources necessary to fight the largest infectious epidemic in North America. In addition, stigma and fear over cost has lead payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of new infections occur in this population.
This study evaluates the effectiveness of treatment of HCV with elbasvir-grasoprevir in PWIDs in a real world, community health clinic setting.
There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory medication assisted therapy with buprenorphine or extended released injectable naltrexone. Cohort two maintains active injection drug use with needle exchange and risk reduction education.
These groups are compared to a 50 patient retrospective cohort of people with substance use disorders at tertiary care hepatology-based treatment program.
All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks.
The investigators hypothesize there is no difference in sustained viremic response at 12 or 48 weeks post-completion of treatment (SVR 12, 48) when treating patients in a community health clinic setting as compared to the standard-of-care subspecialty setting.
Detailed description
Hepatitis C has traditionally been treated in subspecialty health centers given the complexity of older pegylated interferon containing regimens, formerly the standard of care. This model has persisted into the modern era of direct anti-viral agents (DAAs) despite their relative simplicity, creating a bottleneck of human resources necessary to fight the largest infectious epidemic in North America. In addition, stigma and fear over cost has lead payers to restrict treatment in People Who Inject Drugs (PWIDs), even though a majority of new infections occur in this population.
This study evaluates the effectiveness of treatment of hepatitis C virus (HCV) with elbasvir-grasoprevir in people who inject drugs (PWIDs) in a real world, community health clinic setting.
There are two prospective cohorts of PWIDs of 25 patients each, both in primary care-based community health clinics in Portland, Oregon. Cohort one is actively engaged with ambulatory medication assisted therapy with buprenorphine or extended released injectable naltrexone. Cohort two maintains active injection drug use with needle exchange and risk reduction education.
These groups are compared to a 50 patient retrospective cohort of people with substance use disorders at tertiary care hepatology-based Academic Health Center.
All patients have genotype 1 or 4 HCV and are treated with elbasvir-grasoprevir for 12 weeks. The investigators exclude patients who: are under the age of 18; have a history of liver transplant; have failed past treatment of HCV; have an Aspartate aminotransferase Platelet Ratio Index (APRI) > 0.7 or APRI >0.7 but fibrosure/fibroscan of F2 or less; patients with genotype 1a and Nonstructural 5a (NS5a) resistance associated variants (RAVs); have clinical or radiologic evidence of cirrhosis; have aminotransferase levels >10x upper limit of normal; have a hemoglobin of less than 11g/dL, and are co-infected with hepatitis B or HIV.
The investigators hypothesize there is no difference in sustained viremic response at 12 or 48 weeks post-completion treatment (SVR 12, 48) when treating patients with a DAA in a community health clinic setting as compared to the standard-of-care subspecialty setting.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Two parallel investigational groups in different community health clinic treatment settings assigned to treatment with elbasvir-grazoprevir as compared to an academic hepatology clinic retrospective cohort treated with elbasvir-grazoprevir.
| Arm | Type | Receives |
|---|---|---|
| Old Town Clinic, Medication Assisted Therapy group | Active comparator | Drug: elbasvir-grazoprevir (50 mg/100 mg)25 People Who Inject Drugs engaged in a Medication Assisted Therapy treatment program for their substance use disorder, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. |
| Outside In Clinic, Needle Exchange Program | Active comparator | Drug: elbasvir-grazoprevir (50 mg/100 mg)25 People Who Inject Drugs engaged in a Needle Exchange Program with risk reduction education, treated for their HCV using elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. |
| OHSU Hepatology Clinic, Academic center Retrospective Cohort | Other | Drug: elbasvir-grazoprevir (50 mg/100 mg)50 people with substance use disorder and HCV engaged with an Academic Hepatology Clinic (Oregon Health \& Sciences University, OHSU) and treated with elbasvir-grazoprevir (50 mg/100 mg) for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Genotype 1b and genotype 1a without baseline NS5A resistance or Genotype 4
- APRI Score <0.7; if >0.7 a Fibrosure/Fibrotest or Fibroscan score of F2 or less
- No clinical or laboratory evidence of cirrhosis
- Readiness for treatment based on ability to make >2/3 sequential office visits
- Patients must be assessed to have decision-making capacity, be capable of consenting, and not be displaying evidence of overt intoxication.
Key exclusion criteria (6 listed)
- Clinical or Laboratory Evidence of Cirrhosis
- Elevated prothrombin time unrelated to anticoagulation, hemoglobin level less than 12.3 g/L in females and <14 g/L in males, platelet count <150 × 109 cells/L), white blood cells (WBC) <4.0 x103/mm3 , aminotransferase levels more than 10 times the upper limit of normal, or albumin level <3.5 g/L.
- Previous treatment for hepatitis C infection
- Hepatocellular carcinoma
- HIV or hepatitis B virus co-infection
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-grazoprevir (50 mg/100 mg)Also: Zepatier12 week treatment of elbasvir-grazoprevir (50 mg/100 mg) | Drug | OHSU Hepatology Clinic, Academic center Retrospective Cohort, Old Town Clinic, Medication Assisted Therapy group, Outside In Clinic, Needle Exchange Program |
Primary outcome
SVR 12
Time frame: 24 weeks post-initiation of treatment (12 weeks post-completion of treatment)
Sustained Viremic Response at 12 weeks post-completion of treatment. SVR12 was determined negative if undetectable (<20 copies) by polymerase chain reaction and positive if EITHER loss-to-follow up and no lab data or virus was detected greater than 20 copies.
5 secondary outcomes
SVR 48
Time frame: 60 weeks post-initiation of treatment (48 weeks post-completion of treatment)
Discontinuation Rate or Lost To Follow Up
Time frame: Study duration (60 weeks)
NS5A Resistance
Time frame: At Study Screening/Enrollment
Medication Adherence
Time frame: 12 weeks (duration of treatment)
Injection Drug Use Relapse (IDU)
Time frame: Duration of study (60 weeks)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 22938915Islam MM, Topp L, Conigrave KM, White A, Reid SE, Grummett S, Haber PS, Day CA. Linkage into specialist hepatitis C treatment services of injecting drug users attending a needle syringe program-based primary healthcare centre. J Subst Abuse Treat. 2012 Dec;43(4):440-5. doi: 10.1016/j.jsat.2012.07.007. Epub 2012 Aug 29.
- Results publication: PubMed 23884067Bruggmann P, Litwin AH. Models of care for the management of hepatitis C virus among people who inject drugs: one size does not fit all. Clin Infect Dis. 2013 Aug;57 Suppl 2(Suppl 2):S56-61. doi: 10.1093/cid/cit271.
- Results publication: PubMed 23884071Aspinall EJ, Corson S, Doyle JS, Grebely J, Hutchinson SJ, Dore GJ, Goldberg DJ, Hellard ME. Treatment of hepatitis C virus infection among people who are actively injecting drugs: a systematic review and meta-analysis. Clin Infect Dis. 2013 Aug;57 Suppl 2:S80-9. doi: 10.1093/cid/cit306.
- Results publication: PubMed 16183464Sylvestre DL, Litwin AH, Clements BJ, Gourevitch MN. The impact of barriers to hepatitis C virus treatment in recovering heroin users maintained on methadone. J Subst Abuse Treat. 2005 Oct;29(3):159-65. doi: 10.1016/j.jsat.2005.06.002.
- Results publication: PubMed 20425880Grebely J, Knight E, Genoway KA, Viljoen M, Khara M, Elliott D, Gallagher L, Storms M, Raffa JD, DeVlaming S, Duncan F, Conway B. Optimizing assessment and treatment for hepatitis C virus infection in illicit drug users: a novel model incorporating multidisciplinary care and peer support. Eur J Gastroenterol Hepatol. 2010 Mar;22(3):270-7. doi: 10.1097/meg.0b013e32832a8c4c.
- Results publication: PubMed 23616960Newman AI, Beckstead S, Beking D, Finch S, Knorr T, Lynch C, MacKenzie M, Mayer D, Melles B, Shore R. Treatment of chronic hepatitis C infection among current and former injection drug users within a multidisciplinary treatment model at a community health centre. Can J Gastroenterol. 2013 Apr;27(4):217-23. doi: 10.1155/2013/515636.
- Results publication: PubMed 26005037Mason K, Dodd Z, Sockalingam S, Altenberg J, Meaney C, Millson P, Powis J. Beyond viral response: A prospective evaluation of a community-based, multi-disciplinary, peer-driven model of HCV treatment and support. Int J Drug Policy. 2015 Oct;26(10):1007-13. doi: 10.1016/j.drugpo.2015.04.012. Epub 2015 Apr 29.
- Individual participant dataSharing planned: Yes. All electronic data will be maintained encrypted in the Red Cap repository. Only the primary investigator and co-investigator will have access to the master spreadsheet linking study and personal identifiers. Andrew Seaman, co-investigator and primary study contact, will be listed as the repository guardian. He will be responsible for ensuring data are released according to OHSU policy and the institutional review board (IRB) approved repository protocol, executing a repository sharing agreement in case data are released for future research, ensuring the security and confidentiality of all stored data, ensuring the security and confidentiality of data, and tracking releases of data. The repository guardian will be responsible for verifying that future releases are done in concordance with pre-proposed limits and the original consent. Data transport at the time of any future IRB approved data sharing will be approved by an updated research services agreement and separate IRB approval.
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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.
Atif Zaman, MD principal investigator
Oregon Health and Science University
2 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 (50 mg/100 mg) in people with Hepatitis C and Substance Use Disorders, run by Oregon Health and Science University at 2 sites 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 5 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: finished, as of the sponsor's last update on 12 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 12 Nov 2020). 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?
SVR 12 (time frame: 24 weeks post-initiation of treatment (12 weeks post-completion of treatment)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03093415, which also lists 7 linked publications.
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 12 Nov 2020; AzTrials last refreshed its copy on 7 Nov 2026.