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

Information source: Capital Medical University
Information obtained from ClinicalTrials.gov on February 07, 2013
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Chronic Hepatitis B

Intervention: Adefovir Dipivoxil and polyene phosphatidylcholine (Drug); Adefovir Dipivoxil (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: Jun Cheng

Summary

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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: Proportions of subjects with histological response in treatment and control group.

Secondary outcome:

Proportions of subjects in each group who achieve: HBV DNA < 300 copies/mL

Mean log10 reduction from baseline in HBVDNA

ALT normalization rate and range

Liver stiffness values reduction from baseline by Fibroscan

HBeAg loss and HBe seroconversion

HBsAg loss and HBs seroconversion

Improvement in symptoms score

Frequency of adverse events

Frequency of serious adverse events

Frequency of discontinuations from study drug due to adverse events or laboratory abnormalities.

Eligibility

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Beijing Ditan Hospital, Capital Medical University, Beijing 100015, China; Not yet recruiting
Jun Cheng, post doctor, Principal Investigator
Additional Information

Starting date: September 2011
Last updated: September 16, 2011

Page last updated: February 07, 2013

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