An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients With Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
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Information provided by (Responsible Party):
First received: July 27, 2002
Last updated: January 3, 2014
Last verified: January 2014
The purpose of this early access protocol is to provide access to adefovir dipivoxil prior to its commercial availability to people with lamivudine-resistant chronic hepatitis B who have limited treatment options.
Chronic Hepatitis B
Drug: Adefovir Dipivoxil
What is Expanded Access?
||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
Due to the considerable unmet medical need of patients with chronic hepatitis B, Gilead has initiated an early access program to make its investigational drug, adefovir dipivoxil 10 mg, available to those patients with lamivudine-resistant chronic hepatitis B at risk of disease progression. Protocol GS-01-550 provides access to patients with lamivudine-resistant hepatitis B virus who are in need of an alternative treatment to suppress HBV DNA replication and prevent progressive liver disease.
|Ages Eligible for Study:
||16 Years and older
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- =/> 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.
- 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.
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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.
Mutimer D, Pillay D, Shields P, Cane P, Ratcliffe D, Martin B, Buchan S, Boxall L, O'Donnell K, Shaw J, Hübscher S, Elias E. Outcome of lamivudine resistant hepatitis B virus infection in the liver transplant recipient. Gut. 2000 Jan;46(1):107-13.
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).
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.
History of Changes
|Other Study ID Numbers:
|Study First Received:
||July 27, 2002
||January 3, 2014
||United States: Food and Drug Administration
Keywords provided by Gilead Sciences:
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on November 25, 2015
Hepatitis B, Chronic
DNA Virus Infections
Digestive System Diseases
Hepatitis, Viral, Human
RNA Virus Infections
Molecular Mechanisms of Pharmacological Action
Nucleic Acid Synthesis Inhibitors
Reverse Transcriptase Inhibitors