Last updated: 11/07/2018 11:39:16
Renal Safety of Adefovir Dipivoxil (ADV) in Chinese Patients with Chronic Hepatitis B
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: Renal Safety of Adefovir Dipivoxil (ADV) in Chinese Patients with Chronic Hepatitis B
Trial description: The objective of the study is investigating the renal safety of ADV in Chinese patients with chronic hepatitis B (CHB).1013 patients with CHB from 2 Chinese ADV multicenter clinical trials (ADV 30001&106632) were evaluated. All patients were administrated with ADV 10mg daily and 104 weeks results were analysed. Nephrotoxicity is defined by an increase C0.5 mg/dL frombaseline in serum creatinine or a serum phosphorus value of\1.5 mg/dL on two consecutive occasions
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
kidney safety
Timeframe: 2004-2006
Secondary outcomes:
Not applicable
Interventions:
Drug: Adefovir
Enrollment:
1013
Observational study model:
Cohort
Primary completion date:
Not applicable
Time perspective:
Retrospective
Clinical publications:
Yimin, Mao; Mingde, Zeng; Zhang, Wei.Renal safety of adefovir dipivoxil for two-year treatment in Chinese patients with chronic hepatitis B.Chinese J Clin Infect Dis.2014;7(2):121-124
Medical condition
Hepatitis B, Chronic
Product
adefovir
Collaborators
Not applicable
Study date(s)
September 2011 to October 2011
Type
Observational
Phase
4
Participation criteria
Sex
Female & Male
Age
18 - 65 Year
Accepts healthy volunteers
none
- 1. Age between 18–65 years (inclusive)
- 2. Male or female; a female is eligible to enter and participate in this study if she is of:
- 1. Hepatocellular carcinoma as evidenced by one of the following:
- suspicious foci on ultrasound or radiological examination
Inclusion and exclusion criteria
Inclusion criteria:
- Complete abstinence from intercourse throughout the study, and for a time interval after completion or premature discontinuation from the study to account for elimination of the investigational drug, (a minimum of 5 half-lives or longer if the pharmacodynamic profile of the investigational drug warrants a longer time period); or,
- Female sterilization; or,
- Sterilization of male partner; or,
- Implants of levonorgestrel; or,
- Injectable progestogen; or,
- Oral contraceptive (combined or progestogen only); or,
- Any intrauterine device (IUD) with published data showing that the lowest expected failure rate is less than 1% per year (not all IUDs meet this criterion); or,
- Any other methods with published data showing that the lowest expected failure rate for that method is less than 1% per year; or,
- Barrier method only if used in combination with any of the above acceptable methods. 3. The ability to understand and sign a written informed consent prior to any study-related procedure and comply with the requirements of the study. 4. HBV Serology
- Presence of HBsAg at the time of screening and for at least 6 months prior to screening..
- Positive serum HBV DNA assay with screening value 106 copies/mL (Roche COBAS AMPLICORTM HBV MONITOR Test, LLOD <200 copies/mL*) at the time of screening (within 4 weeks of randomisation). * The version of COBAS Amplicor HBV Monitor kit was changed by Roche Diagnostics from a sensitivity of 200 copies/ml to 300 copies/ml without any modification of procedure from the date of 29 Dec 2003. 5. Evidence of elevated serum ALT levels defined as serum ALT level greater than 2.0 times (inclusive) the ULN in the previous 6 months. and Serum ALT levels greater than 1.0 xULN at the time of screening, as determined using laboratory ranges. 6. Agreement not to participate in any other investigational trials or to undertake other HBV systemic antiviral regimens during participation in this study
1. Age between 18–65 years (inclusive) 2. Male or female; a female is eligible to enter and participate in this study if she is of: a. non-childbearing potential (i.e., physiologically incapable of becoming pregnant, including any female who is pre-menarche or post-menopausal); or, b. child-bearing potential, has a negative serum pregnancy test at week 0, and agrees to one of the following:
Exclusion criteria:
- 1. Hepatocellular carcinoma as evidenced by one of the following:
- suspicious foci on ultrasound or radiological examination
- normal ultrasound but a history of rising serum alpha-fetoprotein
- where ultrasound is not available, serum alpha-fetoprotein > 100ng/mL 2. Clinical signs of decompensated liver disease at week 0. These may include but are not limited to:
- serum bilirubin > 3mg/dL (51mol/L)
- prothrombin time 2 seconds prolonged above ULN
- serum albumin < 32g/L
- history of ascites, variceal bleeding, or encephalopathy 3. Serum creatinine at screening > 1.5 mg/dL (> 130 µmol/L). 4. Alanine aminotransferase (ALT) >10 times ULN at screening or history of acute exacerbation leading to transient decompensation 5. Serum Amylase and/or lipase > 2 x ULN 6. Haemoglobin < 10g/dL, WBC count < 3.5 x 109/L, Platelets < 80 x 109/L 7. Documented evidence of active liver disease due to other causes including
- co-infection with hepatitis C virus (HCV), (subjects who are anti-HCV positive and in whom HCV RNA is undetectable are considered to be HCV seropositive and will not be eligible for enrollment),
- co-infection with hepatitis delta virus(HDV),
- co-infection with HIV,
- autoimmune hepatitis (antinuclear antibody titre > 1:160) 8. Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with subject treatment, assessment or compliance with the protocol. This would include any uncontrolled clinically significant renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorder or cancer. 9. Active alcohol or drug abuse or history of alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results. 10. Use of immunosuppressive therapy, immunomodulatory therapy (including interferon or thymosin ,), systemic cytotoxic agents or chronic anti-viral agents including Chinese herbal medicines known to have activity against HBV (e.g. ganciclovir, ADV, entacavir, famciclovir, FTC, DAPD, LFMAU, HBIg) within the previous 6 months or during the study; use of agents that may affect ALT levels (e.g. schisandra agents) at any time during the study. 11. Use of lamivudine within the previous 3 months or during the study. 12. Planned for liver transplantation or previous liver transplantation. 13. Receipt of any investigational drug within within 3 months prior to screening. 14. Therapy with nephrotoxic drugs (e.g., aminoglycosides, amphotercin B, vancomycin, cidofovir, foscarnet, cis-platinum, pentamidine etc.) or competitors of renal excretion (e.g., probenecid) within 2 months prior to study screening or the expectation that subject will receive any of these during the course of the study. 15. History of hypersensitivity to nucleoside and/or nucleotide analogues. 16. Inability to comply with study requirements as determined by the study investigator.
Trial location(s)
No location data available.
Study documents
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Finalized
Actual primary completion date
Not applicable
Actual study completion date
2011-21-10
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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