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

NCT01436539 | Unknown Phase 4 DMC

• 1 other identifier: Ditan-2011-01
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (1)

• Proportions of subjects with histological response in treatment and control group.

  at week 48

Secondary Outcomes (10)

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

  at week 48

• Mean log10 reduction from baseline in HBVDNA

  at week 12, 24, 48

• ALT normalization rate and range

  at week 12 and 48

• Liver stiffness values reduction from baseline by Fibroscan

  at week 48

• HBeAg loss and HBe seroconversion

  at week 12 and 48

Study Arms (2)

Adefovir Dipivoxil and polyene phosphatidylcholine

EXPERIMENTAL

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

Adefovire Dipivoxil

ACTIVE COMPARATOR

Adefovir Dipivoxil 10 mg once daily for 48 weeks

Drug: Adefovir Dipivoxil

Interventions

Adefovir Dipivoxil and polyene phosphatidylcholine DRUG

Adefovir Dipivoxil 10 mg once daily for 48 weeks plus Polyene phosphatidylcholine (PPC) 456 mg three times per day for 48 weeks

Adefovir Dipivoxil and polyene phosphatidylcholine

Adefovir Dipivoxil DRUG

Adefovir Dipivoxil 10 mg once daily for 48 weeks

Adefovire Dipivoxil

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jun Cheng: lead
• Sanofi: collaborator
• Fujian Cosunter Pharmaceutical Co. Ltd: collaborator

Study Sites (1)

Beijing Ditan Hospital, Capital Medical University

Beijing, 100015, China

Location

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

adefovir dipivoxil; polyene phosphatidylcholine

Condition Hierarchy (Ancestors)

Hepatitis B; Blood-Borne Infections; Communicable Diseases; Infections; Hepadnaviridae Infections; DNA Virus Infections; Virus Diseases; Hepatitis, Viral, Human; Hepatitis, Chronic; Hepatitis; Liver Diseases; Digestive System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Vice president

Study Record Dates

• First Submitted: September 13, 2011
• First Posted: September 19, 2011
• Study Start: September 1, 2011
• Primary Completion: March 1, 2013
• Study Completion: July 1, 2013
• Last Updated: September 19, 2011

Record last verified: 2011-09

Locations

CN (1)