- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00042393
An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
A Phase 3b, Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B Who Have Limited Treatment Options
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- =/> 16 years of age (or minimum age required in a given country).
- Prior lamivudine therapy for a cumulative period of > 24 weeks or genotypic evidence of lamivudine resistance.
- Clinical evidence of lamivudine-resistant hepatitis B defined as positive serum hepatitis B virus (HBV) DNA greater than or equal to 10^6 copies/mL (PCR assay) and ALT greater than or equal to 1.2 X upper limit of normal (ULN) within 4 weeks of screening despite ongoing therapy with lamivudine.
- Treating physician feels that the patient is at risk for disease progression.
Screening laboratory values measured as follows, within 28 days prior to the baseline visit:
- Adequate hematologic function.
- Absolute neutrophil count =/> 750/mm3, platelets =/> 50,000/mm3, hemoglobin =/> 7.5 g/dL.
- Females of childbearing potential must have had a negative serum or urine pregnancy test during the screening period. Females must use effective method(s) of contraception during heterosexual intercourse while on adefovir dipivoxil and at least 30 days following treatment discontinuation.
- Able to understand and sign the informed consent prior to undergoing study procedures and able to comply with the requirements of the study.
- Patients co-infected with HIV, hepatitis C virus (HCV), or other viral infections will be eligible to participate provided they meet all other entry criteria.
Patients who do not meet these entry criteria but for whom the treating physician believes that chronic hepatitis B disease progression or premature death is likely to occur in the absence of early access to adefovir dipivoxil will be considered on a case-by-case basis by the Parexel medical monitor.
Exclusion Criteria:
- Patients with any serious or active medical or psychiatric illness that, in the opinion of the investigator, would interfere with patient treatment, assessment, or compliance with the protocol or dosing requirements.
- Patients with hypersensitivity to any of the components of the drug product.
- Currently receiving nephrotoxic drugs (with the exception of cyclosporine or tacrolimus in patients post liver transplantation) such as aminoglycosides (e.g., amikacin, gentamicin, kanamycin, neomycin, netilmicin, streptomycin, tobramycin), conventional amphotericin B, intravenous (IV) vancomycin, cidofovir, IV foscarnet, cisplatin, or IV pentamidine OR competitors of renal excretion such as probenecid and sulfinpyrazone. These agents must be discontinued at least 7 days prior to starting treatment with adefovir dipivoxil.
- Currently enrolled in another clinical trial of adefovir dipivoxil.
- HIV and HBV co-infected patients receiving tenofovir disoproxil fumarate [Viread(R)] for their HIV disease.
- Pregnant or lactating females.
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Publications and helpful links
General Publications
- Benhamou Y, Bochet M, Thibault V, Calvez V, Fievet MH, Vig P, Gibbs CS, Brosgart C, Fry J, Namini H, Katlama C, Poynard T. Safety and efficacy of adefovir dipivoxil in patients co-infected with HIV-1 and lamivudine-resistant hepatitis B virus: an open-label pilot study. Lancet. 2001 Sep 1;358(9283):718-23. doi: 10.1016/s0140-6736(01)05840-8.
- Mutimer D, Feraz-Neto BH, Harrison R, O'Donnell K, Shaw J, Cane P, Pillay D. Acute liver graft failure due to emergence of lamivudine resistant hepatitis B virus: rapid resolution during treatment with adefovir. Gut. 2001 Dec;49(6):860-3. doi: 10.1136/gut.49.6.860.
- Mutimer D, Pillay D, Shields P, Cane P, Ratcliffe D, Martin B, Buchan S, Boxall L, O'Donnell K, Shaw J, Hubscher S, Elias E. Outcome of lamivudine resistant hepatitis B virus infection in the liver transplant recipient. Gut. 2000 Jan;46(1):107-13. doi: 10.1136/gut.46.1.107.
- Perrillo R, Schiff E, Yoshida E, Statler A, Hirsch K, Wright T, Gutfreund K, Lamy P, Murray A. Adefovir dipivoxil for the treatment of lamivudine-resistant hepatitis B mutants. Hepatology. 2000 Jul;32(1):129-34. doi: 10.1053/jhep.2000.8626.
- Perrillo R, Schiff E, Hann H-W L, Buti M, Strasser S, Watkins KM, Moorat AE, Woessner MA, Vig P, Brosgart CL, Bourne EC, and Atkins MC. The addition of adefovir dipivoxil to lamivudine in decompensated chronic hepatitis patients with YMDD variant HBV and reduced response to lamivudine preliminary 24 week results. 2001. Hepatology. 34(4 Pt 2):349A. Abstract 708.
- Schiff E, Neuhaus P, Tillman H, Samuel D, Terrault N, Marcellin P, et al. Safety and efficacy of adefovir dipivoxil for the treatment of lamivudine resistant HBV in patients post liver transplantation. Hepatology 2001 Oct;34 (4, Pt2):446A(Abstract 1098).
- Das K, Xiong X, Yang H, Westland CE, Gibbs CS, Sarafianos SG, Arnold E. Molecular modeling and biochemical characterization reveal the mechanism of hepatitis B virus polymerase resistance to lamivudine (3TC) and emtricitabine (FTC). J Virol. 2001 May;75(10):4771-9. doi: 10.1128/JVI.75.10.4771-4779.2001.
- Peters M, Hann HW, Martin P, Heathcote E, Buggisch P, Moorat AE, et al. Adefovir dipivoxil (ADV) alone and in combination with lamivudine (LAM) supresses LAM-resistant hepatitis B virus (HBV) replication: 16 week interim analysis. Journal of Hepatology. 6(suppl 1): 6-7. 2002 April.
Study record dates
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- RNA Virus Infections
- Virus Diseases
- Infections
- Blood-Borne Infections
- Communicable Diseases
- Liver Diseases
- Hepatitis, Viral, Human
- Hepadnaviridae Infections
- DNA Virus Infections
- Enterovirus Infections
- Picornaviridae Infections
- Hepatitis B
- Hepatitis
- Hepatitis A
- Hepatitis B, Chronic
- Hepatitis, Chronic
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Antiviral Agents
- Reverse Transcriptase Inhibitors
- Nucleic Acid Synthesis Inhibitors
- Enzyme Inhibitors
- Adefovir
- Adefovir dipivoxil
Other Study ID Numbers
- GS-01-550
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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