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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 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.
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).
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02511431
The ClinicalTrials.gov registry entry for NCT02511431 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), which has 490 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo is the first listed.
NCT02511431 reports 0 study locations.
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.
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