NCT02765802

Brief Summary

To evaluate safety and tolerability of lambda over a 48-week treatment period in HDV patients.

Trial Health

90
On Track

Trial Health Score

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

Enrollment
33

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Oct 2016

Geographic Reach
3 countries

4 active sites

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

First Submitted

Initial submission to the registry

May 5, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 9, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 19, 2016

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 20, 2018

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 12, 2018

Completed
4.1 years until next milestone

Results Posted

Study results publicly available

January 17, 2023

Completed
Last Updated

January 17, 2023

Status Verified

December 1, 2022

Enrollment Period

1.8 years

First QC Date

May 5, 2016

Results QC Date

November 2, 2022

Last Update Submit

December 20, 2022

Conditions

Hepatitis D, Chronic

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in HDV Viral Load.

    To evaluate the safety and tolerability of treatment with 2 dose levels of Lambda over a 48 week treatment period. To evaluate the effect of treatment with 2 different doses of Lambda on hepatitis D virus (HDV) ribonucleic acid (RNA) levels.

    Week 48 (end of treatment)

Secondary Outcomes (2)

  • Change From Baseline in HDV Viral Load

    Week 72 (end of follow-up)

  • Number of Patients With a Durable Virologic Response

    Week 72

Study Arms (2)

Lambda 180 μg

EXPERIMENTAL

Lambda 180 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.

Drug: Peginterferon Lambda-1A

Lambda 120 μg

EXPERIMENTAL

Lambda 120 μg once weekly, administered by subcutaneous (SC) injection, for a total of 48 weeks.

Drug: Peginterferon Lambda-1A

Interventions

Peginterferon Lambda-1ADRUG
Also known as: Lambda
Lambda 120 μgLambda 180 μg

Eligibility Criteria

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

You may qualify if:

  • Chronic HDV infection of at least 6 months' duration documented by a positive HDV antibody (Ab) test, detectable and quantifiable HDV RNA by qPCR at study entry
  • Serum alanine aminotransferase (ALT) \> upper limit of the normal range (ULN) and \<10 × ULN at screening
  • Electrocardiogram (ECG) demonstrating no acute ischemia or clinically significant abnormality and a QT interval corrected for heart rate (QTcF) \<450 ms for male patients and \<460 ms for female patients
  • Thyroid-stimulating hormone (TSH) and/or free T4 within 0.8 to 1.2 × ULN, or adequately controlled thyroid function as assessed by the investigator.
  • Dilated retinal examination ≤1 year before screening
  • Female patients of childbearing potential and male patients with partners of childbearing potential must agree to use adequate methods of contraception during the study and through 90 days after the last dose of study medication

You may not qualify if:

  • Participation in a clinical trial with or use of any investigational agent within 30 days before screening, or treatment with interferons (IFNs) or immunomodulators within 12 months before screening
  • Previous use of Lambda. Patients who previously participated in a clinical trial of Lambda but are confirmed to have received placebo or other non-Lambda IFNs are allowed.
  • History or evidence of any intolerance or hypersensitivity to IFNs or other substances contained in the study medication.
  • Female patients who are pregnant or breastfeeding. Male patients must confirm that their female sexual partners are not pregnant.
  • Current or previous history of decompensated liver disease (Child-Pugh Class B or C)
  • Co-infected with human immunodeficiency virus (HIV) or hepatitis C virus (HCV)
  • Past history or current evidence of decompensated liver disease, defined as any of the following at screening:
  • Bilirubin level ≥ 2.5 mg/dL unless due to Gilbert's disease
  • Serum albumin level \<3.5 g/dL
  • International normalized ratio (INR) ≥1.5
  • Alpha fetoprotein ≥100 ng/mL
  • Evidence of significant portal hypertension; current presence or history of variceal bleeding, ascites requiring diuretics or paracentesis, or hepatic encephalopathy
  • Any of the following abnormal laboratory test results at screening:
  • Platelet count \<90,000 cells/mm\^3
  • White blood cell count \<3,000 cells/mm\^3
  • +31 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Soroka Medical Center

Beersheba, 84101, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Auckland City Hospital

Grafton, Auckland, 1142, New Zealand

Location

The Aga Khan University and Hospital

Karachi, 74800, Pakistan

Location

Related Publications (3)

  • Kotenko SV, Gallagher G, Baurin VV, Lewis-Antes A, Shen M, Shah NK, Langer JA, Sheikh F, Dickensheets H, Donnelly RP. IFN-lambdas mediate antiviral protection through a distinct class II cytokine receptor complex. Nat Immunol. 2003 Jan;4(1):69-77. doi: 10.1038/ni875. Epub 2002 Dec 16.

    PMID: 12483210BACKGROUND

  • Sheppard P, Kindsvogel W, Xu W, Henderson K, Schlutsmeyer S, Whitmore TE, Kuestner R, Garrigues U, Birks C, Roraback J, Ostrander C, Dong D, Shin J, Presnell S, Fox B, Haldeman B, Cooper E, Taft D, Gilbert T, Grant FJ, Tackett M, Krivan W, McKnight G, Clegg C, Foster D, Klucher KM. IL-28, IL-29 and their class II cytokine receptor IL-28R. Nat Immunol. 2003 Jan;4(1):63-8. doi: 10.1038/ni873. Epub 2002 Dec 2.

    PMID: 12469119BACKGROUND

  • Wedemeyer H, Manns MP. Epidemiology, pathogenesis and management of hepatitis D: update and challenges ahead. Nat Rev Gastroenterol Hepatol. 2010 Jan;7(1):31-40. doi: 10.1038/nrgastro.2009.205.

    PMID: 20051970BACKGROUND

MeSH Terms

Conditions

Hepatitis D, Chronic

Interventions

peginterferon lambda-1a

Condition Hierarchy (Ancestors)

Hepatitis DHepatitis, Viral, HumanVirus DiseasesInfectionsRNA Virus InfectionsHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

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

Study Officials

  • David Apelian, MD, PhD, MBA

    Eiger BioPharmaceuticals

    STUDY DIRECTOR

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

May 5, 2016

First Posted

May 9, 2016

Study Start

October 19, 2016

Primary Completion

July 20, 2018

Study Completion

December 12, 2018

Last Updated

January 17, 2023

Results First Posted

January 17, 2023

Record last verified: 2022-12

Locations

NZ(1)PA(1)IL(2)