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

September 13, 2011
September 16, 2011
September 2011
March 2013   (final data collection date for primary outcome measure)
Proportions of subjects with histological response in treatment and control group. [ Time Frame: at week 48 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01436539 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of Effects and Safety Between Adefovir Dipivoxil Plus Polyene Phosphatidylcholine Versus Adefovir Dipivoxil Alone in Chronic Hepatitis B Patients
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

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.

Not Provided
Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Chronic Hepatitis B
  • 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
  • Drug: Adefovir Dipivoxil
    Adefovir Dipivoxil 10 mg once daily for 48 weeks
  • 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
    Intervention: Drug: Adefovir Dipivoxil and polyene phosphatidylcholine
  • Active Comparator: Adefovire Dipivoxil
    Adefovir Dipivoxil 10 mg once daily for 48 weeks
    Intervention: Drug: Adefovir Dipivoxil
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
300
July 2013
March 2013   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
China
 
NCT01436539
Ditan-2011-01
Yes
Jun Cheng, Capital Medical University
Jun Cheng
  • Sanofi
  • Fujian Cosunter Pharmaceutical Co. Ltd
Not Provided
Capital Medical University
September 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP