Lonafarnib for Chronic Hepatitis D

This study has been completed.

Sponsor:

Information provided by (Responsible Party):

National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )

ClinicalTrials.gov Identifier:

NCT01495585

First received: December 16, 2011

Last updated: July 18, 2016

Last verified: July 2016

History of Changes

Results First Received: April 28, 2016

Study Type:	Interventional
Study Design:	Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Double (Participant, Care Provider); Primary Purpose: Treatment
Condition:	Hepatitis D
Interventions:	Drug: Lonafarnib Other: Placebo

Participant Flow

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Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
In Group 1, participants were randomized either placebo or lonafarnib 100 mg. In Group2, participants were randomized into either placebo or lonafarnib 200 mg.

Reporting Groups

	Description
Placebo	Two placebo participants in Group1 and two placebo participants in Group 2. The two placebo participants in Group 1 received open label lonafarnib 200 mg.
Lonafarnib 100 mg	6 participants were randomized to Lonafarnib 100 mg.
Lonafarnib 200 mg	4 participants were randomized to Lonafarnib 200 mg.

Participant Flow: Overall Study

	Placebo	Lonafarnib 100 mg	Lonafarnib 200 mg
STARTED	4	6	4
Open Label Lonafarnib 200 mg	2	0	0
COMPLETED	4	6	4
NOT COMPLETED	0	0	0

Baseline Characteristics

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Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Enrolled patients were sequentially assigned into one of two dosing groups which consisted of lonafarnib 100mg in group 1 and lonafarnib 200mg in group 2, with placebo controls in each group. Group1 placebo patients received open-label lonafarnib as group 2 participants.

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.

Enrolled patients were sequentially assigned into one of two dosing groups which consisted of lonafarnib 100mg in group 1 and lonafarnib 200mg in group 2, with placebo controls in each group.

Group1 placebo patients received open-label lonafarnib as group 2 participants.

Reporting Groups

	Description
Placebo	placebo control.
Lonafarnib 100 mg	6 participants were randomized to Lonafarnib 100 mg.
Lonafarnib 200 mg	4 participants were randomized to Lonafarnib 200 mg and two "Placebo" participants in Lonafarnib 100 mg arm received open label lonafarnib 200 mg .
Total	Total of all reporting groups

Baseline Measures

	Placebo	Lonafarnib 100 mg	Lonafarnib 200 mg	Total
Overall Participants Analyzed [Units: Participants]	4	6	6	16

Age [Units: Years] Median (Inter-Quartile Range)	34 (33 to 39)	36 (30 to 42)	45 (38 to 55)	38 (33 to 48)

Gender [Units: Participants]
Female	2	1	2	5
Male	2	5	4	11

Body mass index [Units: Kg/m^2] Median (Inter-Quartile Range)	26.5 (24.1 to 28.9)	22.8 (21.9 to 23.5)	26.1 (25.5 to 27.3)	24.4 (21.9 to 27.3)

Pre-treatment mucleoside analogues [Units: Participants]
yes	1	2	2	5
no	3	4	4	11

Ethnic origin [Units: Participants]
Asian	2	3	3	8
White	1	3	3	7
African	1	0	0	1

Outcome Measures

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1. Primary:

Change in Quantitative Serum HDV RNA Levels After 28 Days of Lonafarnib Therapy. [ Time Frame: 28 days ]

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2. Secondary:

ALT Levels [ Time Frame: 7 months ]

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Serious Adverse Events

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Other Adverse Events

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Limitations and Caveats

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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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More Information

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Certain Agreements:

All Principal Investigators ARE employed by the organization sponsoring the study.

Results Point of Contact:

Name/Title: Dr. Theo Heller
Organization: National Insitute of DIabetes and Digestive and Kidney Diseases
phone: 301-402-7147
e-mail: hellert@mail.nih.gov

Publications:

Glenn JS, Marsters JC Jr, Greenberg HB. Use of a prenylation inhibitor as a novel antiviral agent. J Virol. 1998 Nov;72(11):9303-6.

Rizzetto M, Ponzetto A, Forzani I. Hepatitis delta virus as a global health problem. Vaccine. 1990 Mar;8 Suppl:S10-4; discussion S21-3. Review.

Rosina F, Rizzetto M. Treatment of chronic type D (delta) hepatitis with alpha interferon. Semin Liver Dis. 1989 Nov;9(4):264-6. Review.

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Koh C, Canini L, Dahari H, Zhao X, Uprichard SL, Haynes-Williams V, Winters MA, Subramanya G, Cooper SL, Pinto P, Wolff EF, Bishop R, Ai Thanda Han M, Cotler SJ, Kleiner DE, Keskin O, Idilman R, Yurdaydin C, Glenn JS, Heller T. Oral prenylation inhibition with lonafarnib in chronic hepatitis D infection: a proof-of-concept randomised, double-blind, placebo-controlled phase 2A trial. Lancet Infect Dis. 2015 Oct;15(10):1167-74. doi: 10.1016/S1473-3099(15)00074-2. Epub 2015 Jul 16.

Responsible Party:	National Institutes of Health Clinical Center (CC) ( National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) )
ClinicalTrials.gov Identifier:	NCT01495585 History of Changes
Other Study ID Numbers:	120046 12-DK-0046 ( Other Identifier: NIH Clinical Center )
Study First Received:	December 16, 2011
Results First Received:	April 28, 2016
Last Updated:	July 18, 2016

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