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NCT02511431 · ClinicalTrials.gov registry record · Phase 2
Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
A Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
- Completed
- Registry status
- Phase 2
- Development phase
- 22
- Enrollment target
NCT02511431: Completed Phase 2 study, sponsored by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK).
NCT02511431 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 22 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02511431, 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
- 22 participants
- Enrollment target
Study Summary
Background: \- Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver. There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the drugs lonafarnib and ritonavir can help people with chronic hepatitis D. Objective: \- To find out if treatment of hepatitis D with lonafarnib and ritonavir is safe and effective. Eligibility: \- People 18 years of age and older with chronic hepatitis D. They must not have HIV or other major illnesses. Design: * Participants will be screened with medical history, physical exams, and blood tests. * Participants will have 24 weeks of treatment. They will then have 24 weeks of follow-up. * Participants will be in 1 of 6 treatment groups. Those in each group will receive different doses of the study drugs. Some groups will start with placebo but will receive treatment after 3 months of placebo. * Participants will also take drugs to treat hepatitis B. * Participants will have many visits. These will include: * One three-day stay at the Clinical Center * Physical exams * EKG: small sticky patches will be put on the chest, arms, and legs to trace heart rhythm * Ultrasounds of the abdomen * Urine and blood tests * Stool samples * Eye exams * Evaluations by a reproductive endocrinologist (women) or urologist (men). Men may provide a sperm sample (optional).
Primary Outcome
The number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment
Interventions
- OTHER Placebo
- DRUG Ritonavir
- DRUG Lonafarnib
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2015-07-29 |
| Est. Completion | 2017-02-23 |
| Phase | Phase 2 |
What the finished NCT02511431 record still lists
NCT02511431 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02511431 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02511431 about?
NCT02511431 is a clinical study titled "Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir". Background: \- Chronic hepatitis D is a liver disease caused by the hepatitis D virus (HDV). It can be severe and progressive. Most people with hepatitis D will develop scarring and damage to the liver. There is no FDA approved drug to treat chronic hepatitis D. Researchers want to know if the drug...
What is the current status of trial NCT02511431?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 22 participants. The study started on 2015-07-29. Estimated completion is 2017-02-23.
What interventions are being tested in trial NCT02511431?
The interventions under investigation include: Placebo (OTHER), Ritonavir (DRUG), Lonafarnib (DRUG).
Who is sponsoring clinical trial NCT02511431?
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 NCT02511431's enrollment target sits among peer trials
22 1790th of 2000 higher than 207 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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