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NCT03600714 · ClinicalTrials.gov registry record · Phase 2
Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 26
- Enrollment target
NCT03600714: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT03600714 is a Phase 2 study that has completed, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The registered enrollment target is 26 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03600714, a Phase 2 study, has completed, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 26 participants
- Enrollment target
Study Summary
Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more effective. Lambda interferon stimulates the body s response to viruses. Researchers want to see if combining these drugs fights hepatitis D and helps the liver. Objectives: To see if combining lonafarnib, ritonavir, and lambda interferon is safe and effective to treat chronic hepatitis D infection. Eligibility: Adults at least 18 years old with chronic hepatitis D infection Design: Participants will be screened with a physical exam, medical history, and blood and urine tests. Throughout the study, all participants will: * Follow rules for medicine, food, and contraception * Take hepatitis B medicine * Have weight checked * Have routine blood and urine tests * Give stool samples * Female participants will have pregnancy tests. Participants will have 3 visits before treatment. They will repeat screening tests and have a heart test and liver scan. Participants will have a 5-day inpatient stay. They will: * Baseline blood and urine tests * Have eye tests * Answer health questions * Have a liver sample taken and liver blood pressure measured. Participants will be sedated. * Have reproductive tests * Start the study drugs and have blood draws Over 24 weeks of treatment, participants will: -Take 2 study drugs by mouth every day and 1 as a weekly injection
Primary Outcome
Decline of HDV RNA viral titer of \>2 logs from baseline at 24 weeks of therapy
Interventions
- DRUG Ritonavir
- DRUG Lonafarnib
- DRUG Peg-interferon lambda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 26 participants |
| Start Date | 2018-08-01 |
| Est. Completion | 2020-08-11 |
| Phase | Phase 2 |
What the finished NCT03600714 record still lists
NCT03600714 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 26 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (80% lower).
The record links to 0 conditions, and to 3 interventions - of which Ritonavir is the first listed.
NCT03600714 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03600714 about?
NCT03600714 is a clinical study titled "Treatment of Chronic Delta Hepatitis With Lonafarnib, Ritonavir and Lambda Interferon". Background: Infection with hepatitis D virus leads to a chronic liver disease with no effective treatment. Lonafarnib has improved hepatitis D virus levels in blood, but the medication still needs more research. Ritonavir makes other drugs more effective and is used with lonafarnib to make it more ...
What is the current status of trial NCT03600714?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 26 participants. The study started on 2018-08-01. Estimated completion is 2020-08-11.
What interventions are being tested in trial NCT03600714?
The interventions under investigation include: Ritonavir (DRUG), Lonafarnib (DRUG), Peg-interferon lambda (DRUG).
Who is sponsoring clinical trial NCT03600714?
This trial is sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03600714's enrollment target sits among peer trials
26 1708th of 2000 higher than 282 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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