Trial · NCT02511431
Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
NCT02511431, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2018-05-24
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir. Trials, record NCT02511431. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02511431
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Treatment of Chronic Delta Hepatitis With Lonafarnib and Ritonavir
- NCT number
- NCT02511431
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 22 participants, actual
- Lead sponsor
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Conditions
- Hepatitis D
- Interventions
- Lonafarnib, Ritonavir, Placebo
- First posted
- 2015-07-30
- Last updated
- 2018-09-25
- Results first posted
- 2018-05-24
Source ClinicalTrials.gov
Registered outcomes2
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | 12 weeks | The number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA at 12 weeks of treatment |
| Primary | Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | 24 weeks | The number of participants who experienced a \> 2 log IU/mL decline in serum HDV RNA levels at 24 weeks of treatment |
Source ClinicalTrials.gov
Outcomes2
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | 12 weeks | Participants | COUNT_OF_PARTICIPANTS | |
| PRIMARY | Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | 24 weeks | This outcome is for decline in serum HDV RNA levels over 24 weeks of treatment. Arms 4, 5 and 6 had only 12 weeks of treatment and so are not included in this analysis. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | 50mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | 75mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | 100mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir | 0 | Participants | ||
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | Placebo Then 75mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of Hepatitis Delta Virus (HDV) RNA Quantitative Measurements of >2 Logs From Baseline at 12 Weeks of Treatment | Placebo Then 100mg/100mg Lonafarnib/Ritonavir | 0 | Participants | ||
| Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | 50mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | 75mg/100mg Lonafarnib/Ritonavir | 1 | Participants | ||
| Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | 100mg/100mg Lonafarnib/Ritonavir | 0 | Participants | ||
| Number of Participants With Decline of HDV RNA Quantitative Measurement of > 2 Logs From Baseline at 24 Weeks of Treatment | Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir | 0 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow36
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Treatment | STARTED | 50mg/100mg Lonafarnib/Ritonavir | 4 | |
| Treatment | STARTED | 75mg/100mg Lonafarnib/Ritonavir | 4 | |
| Treatment | STARTED | 100mg/100mg Lonafarnib/Ritonavir | 4 | |
| Treatment | STARTED | Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir | 3 | |
| Treatment | STARTED | Placebo Then 75mg/100mg Lonafarnib/Ritonavir | 3 | |
| Treatment | STARTED | Placebo Then 100mg/100mg Lonafarnib/Ritonavir | 3 | |
| Treatment | COMPLETED | 50mg/100mg Lonafarnib/Ritonavir | 4 | |
| Treatment | COMPLETED | 75mg/100mg Lonafarnib/Ritonavir | 4 | |
| Treatment | COMPLETED | 100mg/100mg Lonafarnib/Ritonavir | 3 | |
| Treatment | COMPLETED | Placebo Then 50 mg/100 mg Lonafarnib/Ritonavir | 3 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 participant flowAdverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | 24 Weeks of 50mg/100mg Lonafarnib/Ritonavir | 0 | 4 | |
| other | Nausea | Gastrointestinal disorders | 24 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 3 | 4 | |
| other | Nausea | Gastrointestinal disorders | 24 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 2 | 4 | |
| other | Nausea | Gastrointestinal disorders | 12 Weeks of Placebo | 3 | 9 | |
| other | Nausea | Gastrointestinal disorders | 12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir | 1 | 3 | |
| other | Nausea | Gastrointestinal disorders | 12 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 2 | 3 | |
| other | Nausea | Gastrointestinal disorders | 12 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 0 | 3 | |
| other | Diarrhea | Gastrointestinal disorders | 24 Weeks of 50mg/100mg Lonafarnib/Ritonavir | 0 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | 24 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 3 | 4 | |
| other | Diarrhea | Gastrointestinal disorders | 24 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 3 | 4 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | 24 Weeks of 50mg/100mg Lonafarnib/Ritonavir | 0 | 4 |
| Total, all-cause mortality | 24 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 0 | 4 |
| Total, all-cause mortality | 24 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 0 | 4 |
| Total, all-cause mortality | 12 Weeks of Placebo | 0 | 9 |
| Total, all-cause mortality | 12 Weeks of 50 mg/100 mg Lonafarnib/Ritonavir | 0 | 3 |
| Total, all-cause mortality | 12 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 0 | 3 |
| Total, all-cause mortality | 12 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 0 | 3 |
| Total, other adverse events | 24 Weeks of 50mg/100mg Lonafarnib/Ritonavir | 3 | 4 |
| Total, other adverse events | 24 Weeks of 75mg/100mg Lonafarnib/Ritonavir | 3 | 4 |
| Total, other adverse events | 24 Weeks of 100mg/100mg Lonafarnib/Ritonavir | 3 | 4 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 30664876 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02511431
GET https://conductscience.org/api/trials/v1/NCT02511431/flow?page=2