Telbivudine in Adults Previously Treated in Idenix-Sponsored Telbivudine Studies

NCT00142298 | Completed Phase 3 Results

• 2 other identifiers: CLDT600A2303NV-02B-022
• Study Type: interventional
• Target: 1,869
• Locations: 21 countries
• Sites: 39

Brief Summary

This trial is being conducted as an open-label, extended-term study for patients with chronic hepatitis B who have previously completed an Idenix-sponsored trial with telbivudine.

Conditions

Chronic Hepatitis B

Outcome Measures

Primary Outcomes (7)

• Percentage of Participants Who Maintained Therapeutic Response [Group A: LdT Pool 2302/015]

  The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  156 weeks, 208 weeks (from feeder study baseline)

• Percentage of Participants Who Maintained Therapeutic Response [Group A: LAM Pool 2302/015]

  The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  52 weeks, 104 weeks

• Percentage of Participants Who Maintained Therapeutic Response [Group A: Feeder Studies 2401/2402/010]

  The maintained therapeutic response is defined as hepatitis B virus (HBV) DNA \< 5 log10 copies/mL and either hepatitis Be antigen (HBeAg) loss or alanine aminotransferase (ALT) normalized. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is defined as ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  52 weeks, 104 weeks

• Percentage of Participants With Maintained Clinical Response [Group B: LdT 2301]

  Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.

  156 weeks, 208 weeks (from feeder study baseline)

• Percentage of Participants With Maintained Clinical Response [Group B: LAM 2301]

  Maintained clinical response is defined as achievement of serum HBV DNA \< 4 log10 copies/mL, normal serum ALT level and improvement or stabilization in Child-Turcotte-Pugh (CTP) score. Total CTP score ranges from 5 to 15; higher scores indicate liver impairment. Improvement is defined as a 2-point or greater reduction in CTP score, and stabilization is defined as a less than 2-point change in CTP score, compared to the patient's baseline value. Analysis was done on the overall per protocol (PP) population and separately for the HBeAg-positive and HBeAg-negative subpopulation.

  52 weeks,104 weeks

• Percentage of Participants With Sustained Therapeutic Response [Group C: LdT Pool and LAM Pool (2302/015)]

  The primary efficacy endpoint for Group C patients was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. HBeAg loss is loss of detectable serum HBeAg in a patient who was HBeAg-positive at feeder baseline. ALT normalized is ALT within normal limits for a patient with an elevated ALT level (\>1.0 × ULN) at either the feeder baseline or feeder screening visit. All efficacy data were analyzed separately for HBeAg-positive and HBeAg-negative patients.

  52 weeks,104 weeks

• Percentage of Participants With Sustained Therapeutic Response [Group C: Other Feeder Studies]

  The primary efficacy endpoint for Group C (other feeder studies) was the percentage of patients with sustained therapeutic response (defined as HBV DNA \< 5 log10 copies/mL and either HBeAg loss or ALT normalized) at Weeks 52 and 104 of off-treatment follow-up. Patients were enrolled for off-treatment follow-up after the treatment discontinuation due to efficacy at their last visit of the feeder studies. Hence, patients did not receive study drug except in case of patients who relapsed and reinitiated treatment. No statistical summary was performed , only patient listing was generated.

  52 weeks,104 weeks

Secondary Outcomes (4)

• To Longitudinally Assess the Longer-term Antiviral Efficacy Achieved With Telbivudine Treatment

  52 weeks, 104 weeks, 156 weeks, 208 weeks

• To Longitudinally Assess the Clinical Efficacy of Longer-term Treatment With Telbivudine

  52 weeks, 104 weeks, 156 weeks, 208 weeks

• To Longitudinally Assess the Durability of HBeAg Responses Achieved With Telbivudine Treatment and Other Previous Treatments in Patients

  52 weeks, 104 weeks, 156 weeks, 208 weeks

• To Determine the Longitudinal Frequency of Virologic Breakthrough and Characterize the Associated Mutations in the HBV Polymerase Gene in HBV DNA Amplified From Sera of Patients With Virologic Breakthrough

  52 weeks, 104 weeks, 156 weeks, 208 weeks

Study Arms (1)

telbivudine

EXPERIMENTAL

telbivudine 600 mg p.o. daily for 104 weeks.

Drug: Telbivudine (LdT)

Interventions

Telbivudine (LdT) DRUG

Telbivudine was to be supplied as white to off-white, oval, bi-convex tablets for the 200 mg tablets and white to off-white ovaloid, slightly curved, beveled edges, film coated tablets for the 600 mg tablets. Study drug (600 mg) was to be self-administered by patients orally (p.o.) in a once daily regimen for 104 weeks; for study consistency, the daily dose had to be taken at the same time each day, with or without food.

Also known as: Sebivo®/Tyzeka®, LdT600

telbivudine

Eligibility Criteria

• Age: 16 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patient completed a previous qualifying Idenix-Sponsored trial with telbivudine
• Patient was not discontinued from previous Idenix-Sponsored study

You may not qualify if:

• Patient is pregnant or breastfeeding
• Patient is co-infected with hepatitis C, hepatitis D or HIV

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (39)

Novartis Investigational Site

Phoenix, Arizona, 85001, United States

Location

Novartis Investigational Site

Los Angeles, California, 90001, United States

Location

Novartis Investigational Site

Los Angeles, California, 90073, United States

Location

Novartis Investigational Site

Pasadena, California, 91103, United States

Location

Novartis Investigational Site

Sacramento, California, United States

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Novartis Investigational Site

San Diego, California, 91945, United States

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Novartis Investigational Site

San Francisco, California, 94115, United States

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Novartis Investigational Site

Sarasota, Florida, United States

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Novartis Investigational Site

Atlanta, Georgia, United States

Location

Novartis Investigational Site

Honolulu, Hawaii, 96812, United States

Location

Novartis Investigational Site

Chicago, Illinois, 60176, United States

Location

Novartis Investigational Site

Boston, Massachusetts, 02215, United States

Location

Novartis Investigational Site

Ann Arbor, Michigan, 48104, United States

Location

Novartis Investigational Site

St Louis, Missouri, 63143, United States

Location

Novartis Investigational Site

New York, New York, 10029, United States

Location

Novartis Investigational Site

Chapel Hill, North Carolina, 27599-7211, United States

Location

Novartis Investigational Site

Philadelphia, Pennsylvania, 19103, United States

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Novartis Investigational Site

Houston, Texas, 77007, United States

Location

Novartis Investigational Site

Richmond, Virginia, 23220, United States

Location

Novartis Investigational Site

Heidelberg, Victoria, 3084, Australia

Location

Novartis Investigational Site

Toronto, Ontario, Canada

Location

Novartis Investigational Site

Beijing, Beijing Municipality, China

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Novartis Investigational Site

Prague, Czechia

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Novartis Investigational Site

Paris, 75270, France

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Novartis Investigational Site

Hanover, 30159, Germany

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Novartis Investigational Site

Hong Kong, 999077, Hong Kong

Location

Novartis Investigational Site

New Delhi, India

Location

Novartis Investigational Site

Nazareth, 1613101, Israel

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Novartis Investigational Site

Torino, Italy

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Novartis Investigational Site

Hamilton, New Zealand

Location

Novartis Investigational Site

Krakow, Poland

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Novartis Investigational Site

Santurce, Puerto Rico

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Novartis Investigational Site

Singapore, Singapore

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Novartis Investigational Site

Seoul, South Korea

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Novartis Investigational Site

Valencia, Spain

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Novartis Investigational Site

Tainan, Taiwan

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Novartis Investigational Site

Bangkok, Thailand

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Novartis Investigational Site

Istanbul, TR-34353, Turkey (Türkiye)

Location

Novartis Investigational Site

London, United Kingdom

Location

Related Publications (1)

• Hsu CW, Chao YC, Lee CM, Chang TT, Chen YC. Efficacy of telbivudine in Taiwanese chronic hepatitis B patients compared with GLOBE extension study and predicting treatment outcome by HBV DNA kinetics at week 24. BMC Gastroenterol. 2012 Dec 13;12:178. doi: 10.1186/1471-230X-12-178.

  PMID: 23234302 DERIVED

MeSH Terms

Conditions

Hepatitis B, Chronic

Interventions

Telbivudine

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

Intervention Hierarchy (Ancestors)

Thymidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 31, 2005
• First Posted: September 2, 2005
• Study Start: March 1, 2005
• Primary Completion: November 1, 2009
• Study Completion: November 1, 2009
• Last Updated: August 21, 2020
• Results First Posted: July 25, 2011

Record last verified: 2020-08

Locations

CN (1); AU (1); CZ (1); PL (1); DE (1); IT (1); NZ (1); KR (1); TW (1); TH (1); TU (1); GB (1); IL (1); FR (1); PR (1); SG (1); ES (1); IN (1); CA (1); HK (1); US (19)