Study of the Efficacy and Safety of Lonafarnib / Ritonavir With and Without Pegylated Interferon -Alfa-2a



Status:Recruiting
Conditions:Hepatitis
Therapuetic Areas:Immunology / Infectious Diseases
Healthy:No
Age Range:18 - Any
Updated:4/3/2019
Start Date:December 1, 2018
End Date:November 1, 2021
Contact:John Ferraro
Email:DLIVR@eigerbio.com
Phone:650-272-6138

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A Phase 3, Matrix Design, Partially Double-Blind, Randomized Study of the Efficacy and Safety of 50 mg Lonafarnib/100 mg Ritonavir BID With and Without 180 mcg PEG IFN-alfa-2a for 48 Weeks Compared With PEG IFN-alfa-2a Monotherapy and Placebo Treatment in Patients Chronically Infected With Hepatitis Delta Virus Being Maintained on Anti-HBV Nucleos(t)Ide Therapy (D-LIVR)

Two LNF-containing regimens will be evaluated in the D-LIVR Phase 3 study: (1) LNF/RTV/PEG
IFN-alfa-2a and (2) LNF/RTV. Each of these arms will have efficacy endpoints that measure
clinical benefit with regard to viral suppression and alanine aminotransferase (ALT)
normalization. For each LNF-containing regimen, a composite endpoint of EOT (48 weeks)
virologic response and ALT normalization will be used. Virologic response will be defined as
a 2 log10 IU/mL reduction from baseline.

This partially double-blind, randomized study will employ a matrix (factorial) design to
evaluate the efficacy and safety of LNF 50 mg/RTV 100 mg twice per day (BID) with and without
PEG IFN-alfa-2a 180 mcg once-weekly (QW) for 48 weeks compared to no treatment (placebo LNF
and placebo RTV) in patients chronically infected with hepatitis delta virus (HDV) and
receiving anti-HBV (hepatitis B virus) nucleos(t)ide maintenance therapy.

Approximately 400 patients will be randomized with an allocation ratio of 7:5:2:2 All
patients will receive/maintain background anti-HBV nucleos(t)ide therapy with entecavir or
tenofovir for at least 12 weeks prior to initiating study therapy.

All patients who complete 48 weeks of treatment will have a liver biopsy for histology
assessment at EOT and will be followed for an additional 24 weeks off study treatment.

Inclusion Criteria:

1. Chronic HDV infection for at least 6 months in duration, documented by a positive HDV
antibody test and HDV RNA ≥ 500 IU/mL.

Note: All genotypes of HDV permitted.

2. Demonstrable suppression of HBV DNA following at least 12 weeks of anti-HBV
nucleos(t)ide treatment with entecavir or tenofovir prior to initiating therapy.

3. Serum ALT > 1.3 x upper limit of the normal range (ULN) and < 10 x ULN.

4. Baseline liver biopsy demonstrating evidence of chronic hepatitis.

5. ECGs demonstrating no acute ischemia or clinically significant abnormality.

6. Normal dilated retinal examination.

Exclusion Criteria:

General Exclusions

1. Previous use of LNF within 12 months.

2. Current or previous history of decompensated liver disease.

3. Co-infected with human immunodeficiency virus or hepatitis C virus (HCV) by detectable
HIV RNA and HCV RNA, respectively.

4. Evidence of significant portal hypertension.

5. Current evidence or history of ascites requiring diuretics or paracentesis, or hepatic
encephalopathy.

6. History of hepatocellular carcinoma.

7. Patients with any of the following:

- Current eating disorder

- Evidence of alcohol substance use disorder.

- Drug abuse within the previous 6 months before screening.

8. Prior history or current evidence of any of the following:

- Immunologically mediated disease,

- Retinal disorder or clinically relevant ophthalmic disorder,

- Any malignancy within 5 years before screening,

- Cardiomyopathy or significant ischemic cardiac or cerebrovascular disease,

- Chronic pulmonary disease,

- Pancreatitis or colitis,

- Severe or uncontrolled psychiatric disorder.

9. Other significant medical condition that may require intervention during the study.

10. Any condition that may impact proper absorption.

11. Therapy with an immunomodulatory agent, IFN-α (eg, IFN alfa-2a or IFN-alfa-2b, or
pegylated IFN-alfa-2a or alfa 2b), cytotoxic agent, or chronic systemic
corticosteroids within 12 months of screening.

12. Use of heparin or warfarin.

13. Systemic antibiotics, antifungals, or antivirals for treatment of active infection
other than HBV.

14. Receipt of systemic immunosuppressive therapy.

15. History or evidence for any intolerance or hypersensitivity to LNF, RTV, PEG
IFN-alfa-2a, tenofovir or entecavir.
We found this trial at
19
sites
601 Elmwood Avenue
Rochester, New York 14642
(585) 275-2100
Principal Investigator: Jonathan Huang, Dr.
Phone: 585-275-0803
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Antwerpen, 2060
Principal Investigator: Bourgeois, Stefan Bourgeois, Dr.
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Bethesda, Maryland 20892
Principal Investigator: Christopher Koh, Dr.
Phone: 301-435-6121
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Chicago, Illinois 60612
Principal Investigator: Nancy Reau, Dr.
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1801 Inwood Rd
Dallas, Texas 75390
(214) 645-3300
Principal Investigator: William Lee, Dr.
University of Texas Southwestern Medical Center UT Southwestern is an academic medical center, world-renowned for...
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Detroit, Michigan 48202
Principal Investigator: Stuart Gordon, Dr.
Phone: 313-916-1962
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Fresno, California 93702
Principal Investigator: Marina Roytman, Dr.
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Houston, Texas 77030
Principal Investigator: John Vierling, Dr.
Phone: 713-798-1966
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5901 West Olympic Boulevard
Los Angeles, California 90036
Principal Investigator: Sergio Rojter, Dr.
Phone: 323-954-0400
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2200 West 3rd Street
Los Angeles, California 90057
Principal Investigator: Ho Bae, Dr.
Phone: 213-207-5793
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Miami, Florida 33136
Principal Investigator: Eugene Schiff, Dr.
Phone: 305-243-1104
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New Haven, Connecticut 06520
Principal Investigator: Joseph Lim, Dr.
Phone: 203-785-3409
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New York, New York 10029
Principal Investigator: Douglas Dieterich, Dr.
Phone: 212-824-7931
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New York, New York 10016
Principal Investigator: Viviana Figueroa-Diaz, Dr.
Phone: 646-962-4742
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Norman, Oklahoma 73069
Principal Investigator: Robert Gordon, Dr.
Phone: 405-329-0474
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Palo Alto, California 94304
Principal Investigator: Paul Kwo, Dr.
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Sacramento, California 95817
Principal Investigator: Stuart Cohen, Dr.
Phone: 916-734-8696
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Sacramento, California 95825
Principal Investigator: Chhaya P Hasyagar, Dr.
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San Diego, California 92120
Principal Investigator: Heather Patton, Dr.
Phone: 619-662-5311
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