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An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options Clinical Trials Facts presented on Clinical Trials Search is not designed to be a substitute for certified medical advice, travels to or professional assistance by using a genuine doctor. We aren't mDs. Always consult your physician about An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options conditions. Clinical Trials Search.org is a website committed to listing clinical research studies in human subjects. An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options Clinical research trials and An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options health trials occur in a lot of of cities throughout the US. A clinical trial or clinical study is a research project with human volunteer subjects. Clinical drug trials and pharmaceutical clinical trials generally evaluate the potency of new does drugs. The role of the studies / undertakings is to figure out specific human healthcare questions. Clinical trials are a popular manner for mDs, government agencies, and private sector companies to locate treatments for all sorts of conditions, including An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options. An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options Clinical Trials and other clinical trials permit volunteers to get medical treatment choices before they are available to the general public. Many times the test subjects get professional assistance for free of charge, and occasionally they are compensated for their time. Sometimes there is a cost for a An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options clinical trial. Human subjects often get the best healthcare possible for their An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options condition. Risks are a reality, nevertheless, and could include additional or frequent dr. calls, medical hazards (perhaps life-threatening), and/or the treatment being ineffectual. Trials are federally governed with exacting guidelines to protect clinical trials patients.
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Home > "A" Clinical Trials Conditions > An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options  An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
For Condition: Chronic Hepatitis B
Status: Recruiting
Sponsor(s): Gilead Sciences ,
Synopsis: 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.
Details: 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.
Eligibility:
Study Type: Interventional, Treatment, Non-Randomized, Open Label, Uncontrolled, Expanded Access Assignment, Safety Study
Minimum Age/Maximum Age: 16 Years/
Genders: Both
Protocol Entry Criteria: Inclusion Criteria 1. =/> 16 years of age (or minimum age required in a given country). 2. Prior lamivudine therapy for a cumulative period of > 24 weeks or genotypic evidence of lamivudine resistance. 3. Clinical evidence of lamivudine-resistant hepatitis B defined as positive serum HBV DNA greater than or equal to 10e6 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. 4. Treating physician feels that the patient is at risk for disease progression. 5. 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. 6. 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. 7. Able to understand and sign the informed consent prior to undergoing study procedures and comply with requirements of the study. 8. Patients co-infected with HIV, 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 chronic hepatitis B disease progression or premature death is likely to occur in absence of early access to adefovir dipivoxil will be considered on a case-by-case basis by the Parexel medical monitor. Exclusion Criteria: 1. 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. 2. Patients with hypersensitivity to any of the components of the drug product. 3. 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, 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. 4. Currently enrolled in another clinical trial of adefovir dipivoxil. 5. HIV and HBV co-infected patients receiving tenofovir disoproxil fumarate (Viread(R)) for their HIV disease. 6. Pregnant or lactating females.
Total Enrollment:
Location and Contact Information:
Additional Information:
Study ID Numbers: GS-01-550;
Study Start Date:
Record last reviewed: July 2002
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00042393
Other Chronic Hepatitis B Studies:
1. Efficacy and safety study of Pegasys in the treatment of chronic hepatitis B
2. An Open-Label Program of Adefovir Dipivoxil in the Treatment of Patients with Lamivudine-Resistant Chronic Hepatitis B With Limited Treatment Options
3. Randomized, Double Blind Trial of LdT (Telbivudine) versus Lamivudine in Adults with Compensated Chronic Hepatitis B
4. Lamivudine and Adefovir to Treat Chronic Hepatitis B Infection in People With and Without HIV Infection
5. Safety and antiviral study of ACH-126, 443 (beta-L-Fd4C) in the treatment of adults with chronic Hepatitis B infection.
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Other Chronic Hepatitis B Clinical Trials
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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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