Trial · NCT01495585

Lonafarnib for Chronic Hepatitis D

NCT01495585, Phase 2, Completed, National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); results first posted 2016-08-31

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Lonafarnib for Chronic Hepatitis D. Trials, record NCT01495585. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01495585

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Lonafarnib for Chronic Hepatitis D
NCT number: NCT01495585
Status: Completed
Phases: Phase 2
Enrollment: 14 participants, actual
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions: Hepatitis D
Interventions: Lonafarnib, Placebo
First posted: 2011-12-20
Last updated: 2016-08-31
Results first posted: 2016-08-31

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.	28 days
Secondary	ALT Levels	7 months

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	Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.	28 days		log(IU/ml)	MEAN
SECONDARY	ALT Levels	7 months		U/L	MEAN

Source ClinicalTrials.gov

Results by group6

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.	Placebo	-0.13	Standard Deviation 0.14	log(IU/ml)
Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.	Group 1	-0.73	Standard Deviation 0.54	log(IU/ml)
Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy.	Group 2	-1.54	Standard Deviation 0.36	log(IU/ml)
ALT Levels	Placebo	18	Standard Deviation 13	U/L
ALT Levels	Group 1	4	Standard Deviation 93	U/L
ALT Levels	Group 2	29	Standard Deviation 85	U/L

Source ClinicalTrials.gov

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	4
Overall Study	STARTED	Lonafarnib 100 mg	6
Overall Study	STARTED	Lonafarnib 200 mg	4
Overall Study	Open Label Lonafarnib 200 mg	Placebo	2
Overall Study	Open Label Lonafarnib 200 mg	Lonafarnib 100 mg	0
Overall Study	Open Label Lonafarnib 200 mg	Lonafarnib 200 mg	0
Overall Study	COMPLETED	Placebo	4
Overall Study	COMPLETED	Lonafarnib 100 mg	6
Overall Study	COMPLETED	Lonafarnib 200 mg	4
Overall Study	NOT COMPLETED	Placebo	0

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events30

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	Placebo	1	4	1
other	Nausea	Gastrointestinal disorders	Group 1	1	6	2
other	Nausea	Gastrointestinal disorders	Group 2	5	6	6
other	Diarrhoea	Gastrointestinal disorders	Placebo	0	4	0
other	Diarrhoea	Gastrointestinal disorders	Group 1	3	6	3
other	Diarrhoea	Gastrointestinal disorders	Group 2	6	6	6
other	Decreased appetite	Gastrointestinal disorders	Placebo	0	4	0
other	Decreased appetite	Gastrointestinal disorders	Group 1	1	6	1
other	Decreased appetite	Gastrointestinal disorders	Group 2	5	6	5
other	Abdominal bloating/dyspepsia	Gastrointestinal disorders	Placebo	1	4	1

1 to 10 of 30Source ClinicalTrials.gov

See all 30 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Group 1
Total, all-cause mortality	Group 2
Total, other adverse events	Placebo	3	4
Total, other adverse events	Group 1	6	6
Total, other adverse events	Group 2	6	6
Total, serious adverse events	Placebo	0	4
Total, serious adverse events	Group 1	0	6
Total, serious adverse events	Group 2	0	6

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
2183511	BACKGROUND	PubMed
2690350	BACKGROUND	PubMed
9765479	BACKGROUND	PubMed
26189433	DERIVED	PubMed
30664876	DERIVED	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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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/NCT01495585

GET https://conductscience.org/api/trials/v1/NCT01495585/events?page=2

API reference For AI assistants