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NCT03248622
Hepatitis B Reactivation During Treatment With Direct-Acting Antiviral Agents for Chronic Hepatitis C Infection
trial in Hepatitis B in 79 participants. Completed in 28 May 2019.
28 May 2019
Quick facts
| Lead sponsor | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) |
|---|---|
| Status | Completed |
| Study type | OBSERVATIONAL |
| Enrollment | 79 |
| Start date | 3 June 2017 |
| Primary completion | 28 May 2019 |
| Estimated completion | 28 May 2019 |
| Sites | 1 location across United States |
Conditions studied
- Hepatitis B — all drugs for Hepatitis B →
Sponsor
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Who can join
18 and older, any sex, with Hepatitis B. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
Background: Treatment of some diseases can suppress the immune system. This can cause other conditions to reactivate. Recent cases have shown that hepatitis B virus (HBV) reactivates in people who had already recovered from it during treatment for chronic hepatitis C (CHC). Their treatment was direct-acting antiviral (DAA) agents. Researchers want to see how common this reactivation is. They want to learn what the effects are. They will study data that have already been collected. Objectives: To study HBV reactivation in people with CHC and resolved HBV infection who are being treated with interferon-free DAA-based therapy. Eligibility: Data were collected from adults 18 and older in studies that were done in 2012 and 2016. Design: Researchers will screen the records from the previous studies. They will identify participants who had HBV infection before they got DAA-based treatment. Researchers will take data from those records. This will include data on: * Age, sex, race, and ethnicity * Treatment and disease status * Lab results Researchers will test stored samples. They will test samples that were taken before, during, and after treatment. They will check if HBV was reactivated. They will also check if other clinical outcomes occurred.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT03248622
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Currently open trials in the same condition.
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- NCT06537414 — A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living Wit · Phase 2 · active not recruiting
- NCT06623071 — Accupower ® HBV Performance Evaluation Quant Kit Bioneer Existation FA 96/384 · recruiting
Other National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) trials
Trials by the same sponsor.
- NCT07313787 — Effects of Meal Macronutrients on Postprandial Lipids · Phase 2 · not yet recruiting
- NCT07388537 — Evaluation of the Clinical Spectrum of Diabetes and Obesity in Youth and Adults · not yet recruiting
- NCT05713799 — Trial of the Combination of Alpha-Lipoic Acid and Mirabegron in Women and in Men With Obesity · Phase 2 · not yet recruiting
- NCT05722210 — Prevalence and Development of Liver Dysfunction in Hematopoietic Stem Cell Transplant · not yet recruiting
- NCT07191561 — Hepatic Lipid Metabolism-Alcohol Use Disorder · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT03248622 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Last refreshed: 30 November 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03248622.
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