NCT00753467

Brief Summary

Open-label, prospective, two part study evaluating IFN-γ 1b at a dose of 200μg by subcutaneous injection every day either alone or in combination with Adefovir dipivoxil or Adefovir dipivoxil alone at a dose of 10mg QD in patients with chronic Hepatitis B.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Sep 2008

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

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

September 1, 2008

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

September 15, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 16, 2008

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2009

Completed
Last Updated

October 21, 2010

Status Verified

September 1, 2008

Enrollment Period

11 months

First QC Date

September 15, 2008

Last Update Submit

October 20, 2010

Conditions

Hepatitis B

Keywords

HBVTreatmentInterferon-gammacombinationHepseraActimmuneHBV DNA

Outcome Measures

Primary Outcomes (1)

  • The primary objective is to evaluate the safety and tolerability of IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.

    30 days

Secondary Outcomes (2)

  • Evaluate the changes in serum HBV DNA concentrations following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.

    30 days

  • Evaluate the changes in liver tests and hematology following administration of Adefovir dipivoxil alone, IFN-γ 1b either alone or in combination with Adefovir dipivoxil in patients with chronic Hepatitis B.

    30 days

Study Arms (3)

1

EXPERIMENTAL

IFN-γ 1b monotherapy: 200 micro-grams daily for 30 days

Drug: IFN-γ 1b (Actimmune)

2

EXPERIMENTAL

IFN-γ 1b 200 micro-grams daily) combination therapy with Adefovir dipivoxil (10 mg daily) for 30 days

Drug: IFN-γ 1b and Adefovir dipivoxil combination

3

ACTIVE COMPARATOR

Adefovir dipivoxil monotherapy (10 mg QD) 30 days

Drug: Adefovir dipivoxil

Interventions

IFN-γ 1b (Actimmune)DRUG

IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose

Also known as: Interferon gamma, Actimmune, Immune Interferon, IFN-gamma
1
Adefovir dipivoxilDRUG

Adefovir dipivoxil: 1 tablet of 10mg given orally QD

Also known as: Hepsera
3
IFN-γ 1b and Adefovir dipivoxil combinationDRUG

IFN-γ 1b: 200μg given SC ED = 2 vials of active drug (0.5 mL from each vial) will be mixed for a total volume of 1.0 mL per dose Adefovir dipivoxil: 1 tablet of 10mg given orally QD

Also known as: Actimmune, Interferon gamma, IFN gamma, Immune Interferon, Hepsera
2

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients must fulfill all of the following criteria to be eligible for enrollment into the study:
  • Men or women age 18 to 75 years
  • Chronic hepatitis B infection based on a history of positive anti-HBsAg and positive for HBV DNA and with or without elevations in liver tests (test to be repeated on screening)

You may not qualify if:

  • Patients with any of the following will be excluded from randomization:
  • Presence of clinically evident cirrhosis including: ascites requiring active diuretic therapy, history of or therapy for hepatic encephalopathy, or history of GI variceal bleeding
  • Platelet count \< 50,000/mm3
  • Serum ALT level \> 10 times upper limit of normal
  • Alpha-fetoprotein level ≥ 200 ng/mL or alpha-fetoprotein level between 50-200 ng/mL in association with liver ultrasound or other radiographic abnormality suspicious for hepatic neoplasm
  • Serum creatinine level \> 1.6 mg/dL
  • Hematology outside of specified limits: neutrophil count \<1000/mm3, hemoglobin \<10 g/dL in males and \<9 g/dL in females
  • Unstable or uncontrolled thyroid disease
  • Treatment with any interferon-α or nucleoside/tide analog within the previous 4 weeks
  • Presence of clinically significant cryoglobulinemia (e.g., skin rash, arthritis, or renal insufficiency due to cryoglobuliemia)
  • Presence or history of autoimmune hepatitis, alpha-1 anti-trypsin deficiency, hemochromatosis, Wilson's disease, drug- or toxin-induced liver disease, alcohol-related liver disease, primary biliary cirrhosis, or sclerosing cholangitis (mild-to-moderate steatosis is acceptable)
  • Chronic hepatitis C infection
  • Hepatits Delta infection (HDV)
  • Known history of HIV infection or positive HIV antibody test by Western Blot (test performed within 60 days of screening can be used to determine eligibility)
  • A disease known to cause significant alteration in immunologic function including hematological malignancy or autoimmune disorder (e.g. rheumatoid arthritis, systemic lupus erythematosis, autoimmune thyroid disease, leukemia, lymphoma, etc)
  • +23 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Huntington Medical Research Institutes

Pasadena, California, 91105, United States

Location

Related Publications (10)

  • Parvez MK, Sehgal D, Sarin SK, Basir SF, Jameel S. Inhibition of hepatitis B virus DNA replicative intermediate forms by recombinant interferon-gamma. World J Gastroenterol. 2006 May 21;12(19):3006-14. doi: 10.3748/wjg.v12.i19.3006.

    PMID: 16718779BACKGROUND

  • Lau JY, Lai CL, Wu PC, Chung HT, Lok AS, Lin HJ. A randomised controlled trial of recombinant interferon-gamma in Chinese patients with chronic hepatitis B virus infection. J Med Virol. 1991 Jul;34(3):184-7. doi: 10.1002/jmv.1890340310.

    PMID: 1919540BACKGROUND

  • Marcellin P, Loriot MA, Boyer N, Martinot-Peignoux M, Degott C, Degos F, Brandely M, Lenfant B, Benhamou JP. Recombinant human gamma-interferon in patients with chronic active hepatitis B: pharmacokinetics, tolerance and biological effects. Hepatology. 1990 Jul;12(1):155-8. doi: 10.1002/hep.1840120124.

    PMID: 2115494BACKGROUND

  • Narayan R, Buronfosse T, Schultz U, Chevallier-Gueyron P, Guerret S, Chevallier M, Saade F, Ndeboko B, Trepo C, Zoulim F, Cova L. Rise in gamma interferon expression during resolution of duck hepatitis B virus infection. J Gen Virol. 2006 Nov;87(Pt 11):3225-3232. doi: 10.1099/vir.0.82170-0.

    PMID: 17030856RESULT

  • Wang J, Michalak TI. Inhibition by woodchuck hepatitis virus of class I major histocompatibility complex presentation on hepatocytes is mediated by virus envelope pre-S2 protein and can be reversed by treatment with gamma interferon. J Virol. 2006 Sep;80(17):8541-53. doi: 10.1128/JVI.00830-06.

    PMID: 16912304RESULT

  • Wieland SF, Eustaquio A, Whitten-Bauer C, Boyd B, Chisari FV. Interferon prevents formation of replication-competent hepatitis B virus RNA-containing nucleocapsids. Proc Natl Acad Sci U S A. 2005 Jul 12;102(28):9913-7. doi: 10.1073/pnas.0504273102. Epub 2005 Jul 1.

    PMID: 15994231RESULT

  • Park SG, Ryu HM, Lim SO, Kim YI, Hwang SB, Jung G. Interferon-gamma inhibits hepatitis B virus-induced NF-kappaB activation through nuclear localization of NF-kappaB-inducing kinase. Gastroenterology. 2005 Jun;128(7):2042-53. doi: 10.1053/j.gastro.2005.03.002.

    PMID: 15940636RESULT

  • Bissett J, Eisenberg M, Gregory P, Robinson WS, Merigan TC. Recombinant fibroblast interferon and immune interferon for treating chronic hepatitis B virus infection: patients' tolerance and the effect on viral markers. J Infect Dis. 1988 May;157(5):1076-80. doi: 10.1093/infdis/157.5.1076. No abstract available.

    PMID: 3129521RESULT

  • Porres JC, Mora I, Gutiez J, Bartolome J, Quiroga JA, Bas C, Compernolle C, Ordi J, Chocarro A, Carreno V. Antiviral effect of recombinant gamma interferon in chronic hepatitis B virus infection: a pilot study. Hepatogastroenterology. 1988 Feb;35(1):5-9.

    PMID: 2452123RESULT

  • Di Bisceglie AM, Rustgi VK, Kassianides C, Lisker-Melman M, Park Y, Waggoner JG, Hoofnagle JH. Therapy of chronic hepatitis B with recombinant human alpha and gamma interferon. Hepatology. 1990 Feb;11(2):266-70. doi: 10.1002/hep.1840110217.

    PMID: 2106474RESULT

Related Links

MeSH Terms

Conditions

Hepatitis B

Interventions

interferon gamma-1bInterferon-gammaadefovir dipivoxil

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

InterferonsCytokinesIntercellular Signaling Peptides and ProteinsPeptidesAmino Acids, Peptides, and ProteinsMacrophage-Activating FactorsLymphokinesProteinsBiological Factors

Study Officials

  • Myron J Tong, Phd, MD

    HMRI

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 15, 2008

First Posted

September 16, 2008

Study Start

September 1, 2008

Primary Completion

August 1, 2009

Study Completion

August 1, 2009

Last Updated

October 21, 2010

Record last verified: 2008-09

Locations

US(1)