NCT02430181

Brief Summary

To Evaluate the Safety and Efficacy of Lonafarnib with and without Ritonavir Boosting in Adults With Genotype 1 Chronic Hepatitis D Virus (HDV) Infection (LOWR-1).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
21

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Nov 2014

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2014

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

April 21, 2015

Completed
9 days until next milestone

First Posted

Study publicly available on registry

April 30, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2015

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2015

Completed
7.1 years until next milestone

Results Posted

Study results publicly available

November 29, 2022

Completed
Last Updated

November 29, 2022

Status Verified

November 1, 2022

Enrollment Period

10 months

First QC Date

April 21, 2015

Results QC Date

November 3, 2022

Last Update Submit

November 3, 2022

Conditions

Chronic Hepatitis D Infection

Outcome Measures

Primary Outcomes (1)

  • Improvement in Quantitative Serum HDV RNA Levels After 4-12 Weeks of Lonafarnib-based Therapy

    log HDV RNA decline from baseline to end of treatment (4-12 weeks of lonafarnib-based therapy)

    4-12 weeks

Study Arms (7)

lonafarnib - I

EXPERIMENTAL

lonafarnib 200 mg BID; n=3

Drug: lonafarnib

lonafarnib - II

EXPERIMENTAL

lonafarnib 300 mg BID; n=3

Drug: lonafarnib

lonafarnib - III

EXPERIMENTAL

lonafarnib 100 mg TID; n=3

Drug: lonafarnib

lonafarnib/PEG IFN-a - I

EXPERIMENTAL

lonafarnib 100 mg BID + PEG IFN-a 180 ug QW; n=3

Drug: lonafarnibDrug: peginterferon alfa-2a

lonafarnib/PEG IFN-a - II

EXPERIMENTAL

lonafarnib 200 mg BID + PEG IFN-a 180 ug QW; n=3

Drug: lonafarnibDrug: peginterferon alfa-2a

lonafarnib/PEG IFN-a - III

EXPERIMENTAL

lonafarnib 300 mg BID + PEG IFN-a 180 ug QW; n=2

Drug: lonafarnibDrug: peginterferon alfa-2a

lonafarnib/ritonavir

EXPERIMENTAL

lonafarnib 100 mg BID + ritonavir 100 mg QD; n=3

Drug: lonafarnibDrug: ritonavir

Interventions

lonafarnibDRUG

antiviral farnesyl transferase inhibitor

Also known as: Sarasar, EBP994
lonafarnib - Ilonafarnib - IIlonafarnib - IIIlonafarnib/PEG IFN-a - Ilonafarnib/PEG IFN-a - IIlonafarnib/PEG IFN-a - IIIlonafarnib/ritonavir
peginterferon alfa-2aDRUG

immunomodulator

Also known as: Pegasys, pegylated interferon-alfa, PEG IFN-alfa, PEG IFN-a
lonafarnib/PEG IFN-a - Ilonafarnib/PEG IFN-a - IIlonafarnib/PEG IFN-a - III
ritonavirDRUG

CYP 3A4 inhibitor, lonafarnib booster

Also known as: Norvir, RTV
lonafarnib/ritonavir

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Males or females, 18 to 65 years of age who are diagnosed with HDV by PCR
  • Chronic hepatitis D infection, genotype 1, documented by a positive anti-HDV Ab test at least of 6 months duration and detectable HDV RNA by PCR within 3 months to study entry
  • Liver biopsy within the last two years
  • Positive viral load by quantitative PCR
  • Electrocardiogram (ECG) shows no acute ischemia or clinically significant abnormality and a QT/QTc interval \<450 milliseconds - using Bazett's correction
  • Females of childbearing potential (intact uterus and within 1 year since the last menstrual period) should be non-lactating and have a negative serum pregnancy test. In addition, these subjects should agree to use one of the following acceptable birth control methods throughout the study:
  • abstinence
  • surgical sterilization (bilateral tubal ligation, hysterectomy, bilateral oophorectomy) six months minimum
  • IUD in place for at least six months
  • barrier methods (condom or diaphragm) with spermicide
  • surgical sterilization of the partner (vasectomy for six months)
  • hormonal contraceptives for at least three months prior to the first dose of study drug
  • Willing and able to comply with study procedures and provide written informed consent

You may not qualify if:

  • Participation in a clinical trial with or use of any investigational agent within 30 days of Study Visit 1
  • Patients co-infected with HIV
  • Patients with screening tests positive for HCV, or anti-HIV Ab
  • History of decompensated cirrhosis within the past year
  • Active jaundice defined by total bilirubin \> 2.0 excluding Gilbert's disease
  • INR ≥ 1.5
  • Eating disorder or alcohol abuse within the past 2 years, excessive alcohol intake (\> 20 g per day for females (1.5 standard alcohol drinks) or \> 30 g per day for males (2.0 standard alcohol drinks) (a standard drink contains 14 g of alcohol: 12 oz of beer, 5 oz of wine or 1.5 oz of spirits) (1.0 fluid oz (US) = 29.57 mL).
  • Drug abuse within the last six months with the exception of cannabinoids and their derivatives
  • Patients with absolute neutrophil count (ANC) \< 1500 cells/mm\^3; platelet count \< 100,000 cells/mm\^3; hemoglobin \< 12 g/dL for women and \< 13 g/dL for men; abnormal TSH,T4, or T3 or thyroid function not adequately controlled; or serum creatinine concentration ≥ 1.5 times upper limit of normal (ULN)
  • History or clinical evidence of any of the following:
  • variceal bleeding, ascites, hepatic encephalopathy, CTP score \> 6, decompensated liver disease or any other form of non-viral hepatitis
  • immunologically mediated disease (e.g., rheumatoid arthritis, inflammatory bowel disease, severe psoriasis, systemic lupus erythematosus) requiring more than intermittent nonsteroidal anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids (inhaled asthma medications are allowed)
  • any malignancy within 3 years except for basal cell skin cancer
  • significant or unstable cardiac disease (e.g., angina, congestive heart failure, uncontrolled hypertension, history of arrhythmia)
  • chronic pulmonary disease (e.g., chronic obstructive pulmonary disease) associated with functional impairment
  • +3 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ankara University Medical School

Ankara, Turkey (Türkiye)

Location

Related Links

MeSH Terms

Interventions

lonafarnibpeginterferon alfa-2aRitonavir

Intervention Hierarchy (Ancestors)

ThiazolesSulfur CompoundsOrganic ChemicalsAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Results Point of Contact

Title
Senior VP, Clinical Development
Organization
Eiger BioPharmaceuticals, Inc
info@eigerbio.com
1-650-618-1621

Study Officials

  • Cihan Yurdaydin, MD

    Ankara University

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 21, 2015

First Posted

April 30, 2015

Study Start

November 1, 2014

Primary Completion

September 1, 2015

Study Completion

November 1, 2015

Last Updated

November 29, 2022

Results First Posted

November 29, 2022

Record last verified: 2022-11

Locations

TU(1)