Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

Hepatitis B, Chronic Clinical Trial

Official title:

Dose-Ranging Study of Pradefovir in Patients With Compensated Hepatitis B

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00230503
• Other study ID #: RNA200103-201
• Status: Completed
• Phase: Phase 2
• First received: September 28, 2005
• Last updated: June 21, 2012
• Start date: June 2004
• Est. completion date: December 2006

Study information

• Verified date: June 2012
• Source: Valeant Pharmaceuticals International, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

• Compare the safety of four oral doses of pradefovir after 48 weeks of treatment

• Select the dose of pradefovir for Phase 3 studies

Description:

• Compare the safety of four oral doses of pradefovir after 48 weeks of treatment

• Compare the antiviral activity of four oral doses of pradefovir to adefovir and dipivoxyl after 48 weeks of treatment

• Select the dose of pradefovir for Phase 3 studies

• Determine the pharacokinetic profiles of four oral doses of pradefovir

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: December 2006
• Est. primary completion date: December 2006
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Compensated chronic HBV Infection

• No prior treatment with adefovir dipivoxil

• No interferon or lamivudine treatment for three months prior to enrollment

• HBeAg positive or negative

• HBV DNA viral load greater than 500,000 copies per mL

• ALT between 1.2 and 10 times ULN

Exclusion Criteria:

• Positive HIV, HCV, and/or HDV serology

• History of renal tubular necrosis

• Serum creatinine greater than 2.0 mg/dl

• History of organ transplant or use of immunosuppresive drugs

• Pregnant or breast-feeding females

Study Design

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis B, Chronic

Intervention

Drug:
• pradefovir mesylate

• adefovir dipivoxyl

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Valeant Pharmaceuticals International, Inc.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	- Safety: Clinical examinations of laboratory tests
Primary	- Efficacy: Change in viral load over time
Secondary	- Efficacy: Proportion of patients with undetectable viral load