A Phase 4 interventional study of Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier] in Hepatitis C, Hemodialysis and Nosocomial Infection, sponsored by University of Pennsylvania. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-12-15.
Sponsored by University of Pennsylvania · Phase 4, Interventional, and Treatment
Among 725 studies in Hepatitis C with a site in United States — 29 open to participants now, 37 under way, 1 of them phase 3. Hepatitis C · United States.
Among the 725 studies in Hepatitis C with a site in United States, this one is the 543rd largest by enrollment of the 594 interventional ones that give a count, is one of 27 that started in 2019, is one of 85 in phase 4, and was the 602nd registered.
1,743 studies on the registry are indexed under Hepatitis C; 97 are open to participants now.
Browse Hepatitis C studies →29 of the 725 studies in Hepatitis C with a site in United States are open now. Recruiting first, the newest first:
National Institute of Allergy and Infectious Diseases (NIAID) · Sites in United States
Ages 16–45 · Women only
University of Washington · Sites in United States
Ages 18+
West Virginia University · Sites in United States
Ages 18+ · Healthy volunteers
University of California, Los Angeles · Sites in United States
Ages 18–59 · Men only · Healthy volunteers
University of Southern California · Sites in United States
Ages 18+
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 56 Hepatitis C studies recruiting now, 43 (77%) set no upper age limit and 6 (11%) stop at 75 or younger; 10 take children under 18; 26 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
725 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 115 · Phase 2 186 · Phase 3 100 · Phase 4 85
First in 1981; this study’s year is marked. 27 started in 2019.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 6 is below the median of 72 across 1,223 interventional studies indexed under Hepatitis C.
Median enrollment 60 across the 594 interventional studies, 113 across the 127 observational. Of the 633 that completed or were terminated, 286 (45%) have results posted.
This tab as a report to print or save as PDF → With an account.
286 of 725 have an industry lead sponsor. The 10 most frequent:
University of Pennsylvania is the lead sponsor of 1,668 studies on the registry; 235 are open to participants now.
Of its 158 completed or terminated interventional studies of FDA-regulated products, 109 (69%) have results posted.
University of Pennsylvania has 6 studies filed under Hepatitis C — fewer than ten, so there is no comparison to draw.
13 of the studies in Hepatitis C with a site in United States that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06367465Washington University School of MedicineFeasibility and Acceptability of HCV Treatment in Pregnancy | 2026-12-28 |
| NCT06870019University of Southern CaliforniaHepatitis C Tracker Study | 2026-12-31 |
| NCT06953479LifespanImplementing Low-Barrier HCV Treatment in a Jail Setting | 2027-01 |
| NCT07631559University of California, San FranciscoPilot Study of an Adapted Partner Navigation Intervention Booster Session for Sustained Healthcare Engagement Among People Who Inject Drugs | 2027-03-01 |
| NCT06179498University of California, San FranciscoPartner Navigation Intervention for Hepatitis C Treatment Among Young People Who Inject Drugs | 2027-03-01 |
Among the 725 studies in Hepatitis C with a site in United States, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is a study to define strategies for Nephrologists to directly supervise and apply direct acting antivirals to cure hepatitis C in hemodialysis patients. Strategies will include identification of candidate patients, application for insurance approval, specifics of direct acting antiviral therapy (Zepatier with or without ribavirin) and laboratory monitoring during and after therapy.
Background - Hepatitis C (HCV) is common in hemodialysis (HD) patients with reported prevalences of 25%, By 2020, predicted 775,000 hemodialysis patients in the US, of whom 109,000 will have HCV. Hepatitis C is associated with increased mortality in HD patients, decreased kidney allograft survival, and a source of nosocomial infection in hemodialysis units. Currently drugs to cure HCV - direct acting antivirals (DAA) which can be safely given to HD patients are now available. A significant portion of the medical care provided to HD patients is by Nephrologists and HD staff.
Goals of Protocol - 1. Provide guidelines for implementation and monitoring of DAA therapy in HD patients with HCV 2. Provide Nephrologists strategies for identification of candidate HD patients, obtainment of third party approval for DAA payment, specific drug dosing protocols based on genome type of HCV, and laboratory and clinical monitoring during DDA therapy. 3, By reducing the pool of HCV patients in a HD Unit, the risk of nosocomial transmission of HCV t o other patients and staff will be reduced
Study Design - an interventional, prospective, non-randomized, non-blinded trial to evaluate real world strategies to identify and treat HCV infected patients with Zepatier
Study Procedures 1. Patients who meet inclusion criteria without exclusion criteria be assigned treatment with Zepatier with or without Ribavirin according to following schedule: (a) Genotype 1a - treatment naive without NS5A polymorphism - Zepatier one tablet (100 mg grazoprevir and 50 mg elbasvir) per day for 12 weeks (b) Genotype 1a - treatment naiive with NS5A polymorphism - Zepatier one tablet daily and ribavirin (200 mg) daily for 16 weeks (c) Genotype 1b-treatment naive - Zepatier one daily for 12 weeks (d) Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - Zepatier and ribavirin each once daily for 12 weeks (e) Genotype 4 - treatment naive - Zepatier one daily for 12 weeks (f)Genotype 4 -prior treatment - Zepatier and ribavirin each once per day for 16 weeks
Baseline/Screening Testing: 1. HCV genotype testing 2. HCV viral RNA load 3. Liver function tests 4, Protime, Partial Thromboplastin time 5. HIV - if positive, then determine viral RNA and CD4 and T cell count 6. Liver biopsy (within 24 mo of treatment) or Fibroscan within 12 mo of treatment 7. Hepatitis BsAg 8. For patients with HCV genotype 1a, test fro NS5A mutation
Treatment of HIV/HCV co-infected patients will be done in collaboration with the HIV treating physician to determine if any adjustments in the HIV drug regimen will be required
Testing/Evaluations during Active DAA Treatment - 1. LFT and RNA HCV viral load at week 4, 8, and 12. For patients on 16 weeks of treatment, LFT at week 16 as well 2. For patients on combination Zepatier and ribavirin, hemoglobin monitoring every week during treatment 3. Clinical pharmacology evaluation for compliance and adverse events at week 4,8,and 12 (and week 16 for patients on 16 week treatment)
Testing/Evaluation Post DAA Treament - 1, RNA viral load at 12 weeks post treatment 2. Clinical Pharmacologoy evaluation 12 weeks post treatment for adverse events 3. patients who achieve sustained viral remission at 12 weeks will be identified in HD records as HCV ab positive but HCV viral load RNA negative
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Reproductive potential
Able to have children. For women this usually means from the first period until menopause, unless permanently unable to through surgery; for men, unless permanently sterile. Read who the line is about — participants, women, men, or their partners.
Criteria about it usually ask for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Child-Pugh class
A score of how well the liver works in people with liver disease such as cirrhosis: class A is mild, B moderate and C severe.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
CYP3A (CYP3A4) inhibitors and inducers
CYP3A is a group of enzymes, mainly CYP3A4, in the liver and gut that break down many medicines. Some medicines, supplements and foods (grapefruit, St John’s wort) slow them down or speed them up, which changes how much of a study drug stays in the body.
Studies list them so they can be avoided or switched; bring a list of everything you take, including supplements.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ECG (electrocardiogram)
A recording of the heart’s electrical activity, taken with stickers on the chest, arms and legs. It takes a few minutes and does not hurt.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Genotype 1a - treatment naive without NS5A polymorphism - Drug Intervention : Oral administration Elbasvir (50mg)/Grazoprevir (100mg) one tablet per day for 12 weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Genotype 1a - treatment naiive with NS5A polymorphism - Oral administration of Elbasvir/Grazoprevir one tablet daily and ribavirin (200 mg) daily for 16 weeks weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Genotype 1b-treatment naive - Oral administration of Elbasvir/Grazoprevir one daily for 12 weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Genotype 1a or 1b - prior treatment with INF or HCV NS3/4A protease inhibitor - oral administration of Elbasvir/Grazoprevir and ribavirin each once daily for 12 weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
(e) Genotype 4 - treatment naive - oral administration of Elbasvir/Grazoprevir one daily for 12 weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Genotype 4 -prior treatment - oral administration of Elbasvir/Grazoprevir and ribavirin each once per day for 16 weeks
Drug: Elbasvir 50 MG / Grazoprevir 100 MG [Zepatier]
Same as described in arm description
Also known as: Ribavirin 200 mg
SVR - Sustained Virologic Response
Absence of HCV by viral RNA quantitation at 12 weeks post treatment
Time frame: 12 weeks after completion of Elbasivir/Grazoprevir treatment
Approval for DAA by Third Party Payers
The number of participants for whom their third party insurance approved payment of the DAA (study drug)
Time frame: Within one month of last patient enrolled
Patients from an outpatient hemodialysis unit were recruited between October 2019 and April 2020
| Milestone | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment |
|---|---|---|---|---|---|---|
| Started | 3 | 0 | 1 | 0 | 0 | 0 |
| Completed | 3 | 0 | 1 | 0 | 0 | 0 |
| Not completed | 0 | 0 | 0 | 0 | 0 | 0 |
Absence of HCV by viral RNA quantitation at 12 weeks post treatment
| Participants | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment |
|---|---|---|---|---|---|---|
| SVR - Sustained Virologic Response | 3 | 0 | 1 | 0 | 0 | — |
The number of participants for whom their third party insurance approved payment of the DAA (study drug)
| Participants | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment |
|---|---|---|---|---|---|---|
| Approval for DAA by Third Party Payers | 0 | — | 0 | — | — | — |
Collected over 24 weeks from start of therapy. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Genotype 1a -Rx Naive -no NS5A Polymorph | 0/3 (0%) | 0/3 (0%) | 0/3 (0%) |
| Genotype 1a, Rx Naive + NS5A Polymorph | — | — | — |
| Genotype 1b - Rx Naive | 0/1 (0%) | 0/1 (0%) | 0/1 (0%) |
| Genotype 1a/1b -Prior INF or NS3/4A | — | — | — |
| Genotype4 - Treatment Naive | — | — | — |
| Genotype 4- Prior Treatment | — | — | — |
Genotype 1a, Rx naive + NS5A polymorph, Genotype 1a/1b - prior INF or NS3/4A, Genotype 4- treatment naive and prior treatment - none of the recruited patients fell into these categories after initial screening
| Age, Categorical(Participants) | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment | Total |
|---|---|---|---|---|---|---|---|
| <=18 years | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | — | 0 | 0 | 0 | 0 | 0 |
| >=65 years | 3 | 0 | 1 | 0 | 0 | 0 | 4 |
| Sex: Female, Male(Participants) | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment | Total |
|---|---|---|---|---|---|---|---|
| Female | 1 | — | 0 | — | — | — | 1 |
| Male | 2 | — | 1 | — | — | — | 3 |
| Race (NIH/OMB)(Participants) | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment | Total |
|---|---|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | — | 0 | — | — | — | 0 |
| Asian | 0 | — | 0 | — | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | — | 0 | — | — | — | 0 |
| Black or African American | 3 | — | 1 | — | — | — | 4 |
| White | 0 | — | 0 | — | — | — | 0 |
| More than one race | 0 | — | 0 | — | — | — | 0 |
| Unknown or Not Reported | 0 | — | 0 | — | — | — | 0 |
| Region of Enrollment(participants) | Genotype 1a -Rx Naive -no NS5A Polymorph | Genotype 1a, Rx Naive + NS5A Polymorph | Genotype 1b - Rx Naive | Genotype 1a/1b -Prior INF or NS3/4A | Genotype4 - Treatment Naive | Genotype 4- Prior Treatment | Total |
|---|---|---|---|---|---|---|---|
| United States | 3 | — | 1 | — | — | — | 4 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — No research reason to share IPD to other researchers
Ran from Sep 2019 to primary completion in May 2020, 7 months.
Results were first posted in Dec 2021, 1 year 7 months after primary completion.
Of 56 non-industry phase 4 interventional studies under Hepatitis C, half reached primary completion within 24 months of starting (the median), counting those still running; a quarter within 17 and three quarters within 49. This study's 7 months is below that.
Counting every sponsor, half of 58 studies reached it within 24 months; a quarter within 16 and three quarters within 48.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Nov 2021. You cannot join it, but the record below documents what was studied.
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