Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by Capital Medical University.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborators:
Sanofi
Fujian Cosunter Pharmaceutical Co. Ltd
Information provided by (Responsible Party):
Jun Cheng, Capital Medical University
ClinicalTrials.gov Identifier:
NCT01436539
First received: September 13, 2011
Last updated: September 16, 2011
Last verified: September 2011
  Purpose

The purpose of the study is to evaluate the effects and safety of Adefovir Dipivoxil plus polyene phosphatidylcholine compared to Adefovir Dipivoxil alone in patients with chronic hepatitis B.


Condition Intervention Phase
Chronic Hepatitis B
Drug: Adefovir Dipivoxil and polyene phosphatidylcholine
Drug: Adefovir Dipivoxil
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Multi-center, Open Label, Randomized Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Capsule Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients

Resource links provided by NLM:


Further study details as provided by Capital Medical University:

Primary Outcome Measures:
  • Proportions of subjects with histological response in treatment and control group. [ Time Frame: at week 48 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportions of subjects in each group who achieve: HBV DNA < 300 copies/mL [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • Mean log10 reduction from baseline in HBVDNA [ Time Frame: at week 12, 24, 48 ] [ Designated as safety issue: No ]
  • ALT normalization rate and range [ Time Frame: at week 12 and 48 ] [ Designated as safety issue: No ]
  • Liver stiffness values reduction from baseline by Fibroscan [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
  • HBeAg loss and HBe seroconversion [ Time Frame: at week 12 and 48 ] [ Designated as safety issue: No ]
  • HBsAg loss and HBs seroconversion [ Time Frame: at week 12 and 48 ] [ Designated as safety issue: No ]
  • Improvement in symptoms score [ Time Frame: at week 12, 24 and 48 ] [ Designated as safety issue: No ]
  • Frequency of adverse events [ Time Frame: up to 60 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of serious adverse events [ Time Frame: up to 60 weeks ] [ Designated as safety issue: Yes ]
  • Frequency of discontinuations from study drug due to adverse events or laboratory abnormalities. [ Time Frame: up to 60 weeks ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 300
Study Start Date: September 2011
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Adefovir Dipivoxil and polyene phosphatidylcholine
Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks
Drug: Adefovir Dipivoxil and polyene phosphatidylcholine
Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks
Active Comparator: Adefovire Dipivoxil
Adefovir Dipivoxil 10 mg once daily for 48 weeks
Drug: Adefovir Dipivoxil
Adefovir Dipivoxil 10 mg once daily for 48 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Males and females between the age of 18 to 65 years with chronic hepatitis B.
  • HBsAg positive for a minimum of 6 months.
  • HBV DNA ≥4 log10 copies/ml, and ≤ 6 log10 copies/mL
  • Alanine aminotransferase (ALT) ≥ 2 times the upper limit of normal(ULN) and ≤10 times ULN, and documented ALT abnormal within 6 month prior to the study screening.
  • Had a liver biopsy performed within 6 months prior to randomization and has readable biopsy slides or agrees to have a biopsy performed prior to entry.
  • Willing and able to provide written informed consent.

Exclusion Criteria:

  • Received any nucleoside, nucleotide or interferon therapy within 6 months prior to the screening.
  • Previous treatment with lamivudine, adefovir, entecavir or telbivudine and occurred viral breakthrough or genotype resistance.
  • Received immunosuppressive agents or other immunoregulates (including thymosin),systemic cytotoxic drugs, other antiviral agents including Chinese herb medicine within 6 months prior to the screening.
  • Active alcohol intake( more than 20g/d for female or more than 30g/d for male) or drug abuse within 1 year prior to screening. Alcohol or drug abuse considered by the investigator to be sufficient to hinder compliance with treatment, participation in the study or interpretation of results.
  • ALT is greater than 10 times ULN at screening or has the history of transient decompensated liver disease due to acute exacerbation.
  • Any of the laboratory test at screening as the following :

    • serum creatinine > 1.5 mg/dl ;
    • prothrombin time ≥ 4 seconds prolonged or PTA <60%;
    • serum albumin<32 g/L;
    • serum bilirubin>3.0mg/dL;
    • Hemoglobin<11g/dL(males) or <10 g/dL(females), white blood cells count<3.5 x 10^9/L, absolute neutrophil count <1.5 x 10^9/L, platelets<80 x 10^9/L.
  • Patient is coinfected with HCV, HDV or HIV.
  • Hepatocellular carcinoma (HCC), or the presence of a mass on imaging studies of the liver that is suggest of HCC, or an alpha-fetoprotein (AFP)> 500ng/mL.
  • Decompensated liver disease as defined by serum bilirubin >3mg/dL, prothrombin time≥ 4 seconds prolonged, a serum albumin<32g/L, or a history of ascites, variceal bleeding or hepatic encephalopathy.
  • Presence of other causes of liver disease (i.e.alcoholic liver disease,autoimmune hepatitis, hemochromatosis, Wilson disease, nonalcoholic steatohepatitis, alpha-1anti-trypsin deficiency).
  • Any serious or active medical or psychiatric illnesses other than hepatitis B which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. This would include, may not limit to, renal, cardiac, pulmonary, vascular, neurogenic, digestive, metabolic (diabetes, thyroid disorders, adrenal disease), immunodeficiency disorders, active infection or cancer.
  • BMI≥30.
  • Patient is pregnant or breast-feeding.
  • Planned for liver transplantation or previous liver transplantation.
  • Need take hepatotoxic drugs (e.g.,dapsone, erythromycin, fluconazole, rifampin, etc) and nephrotoxic drugs (e.g., NSAIDs, aminoglycosides, amphotericin B, foscarnet, etc.) for long time.
  • History of hypersensitivity to nucleoside analogues.
  • Previous (or planned) participation in an investigational trial involving administration of investigational compound within 12 weeks prior to the study screening.
  • Poor compliance of the patient considered by investigator.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01436539

Locations
China
Beijing Ditan Hospital, Capital Medical University Not yet recruiting
Beijing, China, 100015
Principal Investigator: Jun Cheng, post doctor         
Sponsors and Collaborators
Jun Cheng
Sanofi
Fujian Cosunter Pharmaceutical Co. Ltd
  More Information

No publications provided

Responsible Party: Jun Cheng, Vice president, Capital Medical University
ClinicalTrials.gov Identifier: NCT01436539     History of Changes
Other Study ID Numbers: Ditan-2011-01
Study First Received: September 13, 2011
Last Updated: September 16, 2011
Health Authority: China: Ethics Committee

Additional relevant MeSH terms:
Hepatitis
Hepatitis A
Hepatitis B
Hepatitis, Chronic
Hepatitis B, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Hepadnaviridae Infections
DNA Virus Infections
Adefovir
Adefovir dipivoxil
Polyene phosphatidylcholine
Antiviral Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Reverse Transcriptase Inhibitors
Nucleic Acid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anti-Retroviral Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents

ClinicalTrials.gov processed this record on July 24, 2014