Trial record 65 of 431 for:
hepatitis b | Open Studies
Evaluating the Efficacy, Safety and Tolerability of Tenofovir DF in Pediatric Patients With Chronic Hepatitis B Infection
This study is currently recruiting participants.
Verified February 2013 by Gilead Sciences
Sponsor:
Gilead Sciences
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01651403
First received: July 25, 2012
Last updated: June 5, 2013
Last verified: February 2013
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Purpose
This placebo-controlled study evaluates the efficacy, safety and tolerability of TDF in patients 2 to <12 years old with chronic Hepatitis B infection. While studies have shown significant virologic response in adults and adolescents, the effect in children is not well established. This study will provide valuable data that can help establish the efficacy and safety profiles of TDF in children.
| Condition | Intervention | Phase |
|---|---|---|
|
Chronic Hepatitis B Infection |
Drug: Tenofovir DF Drug: Tenofovir DF Placebo |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | A Randomized, Double-Blind Evaluation of the Antiviral Efficacy, Safety, and Tolerability of Tenofovir Disoproxil Fumarate Versus Placebo in Pediatric Patients With Chronic Hepatitis B Infection |
Resource links provided by NLM:
Drug Information available for:
Formic acid
Tenofovir
Tenofovir Disoproxil Fumarate
Recombinant Hepatitis B vaccine
Hepatitis A Vaccines
U.S. FDA Resources
Further study details as provided by Gilead Sciences:
Primary Outcome Measures:
- Proportion of patients with serum HBV DNA < 400 copies/mL at week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Proportion of patients with HBeAg seroconversion at week 72 [ Time Frame: Week 72 ] [ Designated as safety issue: No ]
- Cumulative Incidence of at least 4% decrease from baseline in bone mineral density of lumbar spine [ Time Frame: Week 72 ] [ Designated as safety issue: Yes ]
- Percent change from baseline in bone mineral density of lumbar spine [ Time Frame: Week 72 ] [ Designated as safety issue: Yes ]
- Safety and Tolerability of Therapy [ Time Frame: Up to Week 192 ] [ Designated as safety issue: Yes ]Safety and tolerability is measured by the frequency of laboratory abnormalities reported as adverse events.
- Biochemical and serological responses [ Time Frame: Week 72 ] [ Designated as safety issue: No ]Biochemical and serological responses as measured by normal/normalization of ALT, proportion of subjects with HBV DNA < 400 copies/mL and normal ALT, proportion of subjects with HBV DNA < 169 copies/mL, proportion of subjects with HBsAg loss and seroconversion
- Viral Resistance [ Time Frame: Weeks 72, 144, 192 or Early Discontinuation ] [ Designated as safety issue: No ]Genotypic changes from baseline within the HBV polymerase for patients who were viremic (HBV DNA > or equal 400 copies/mL) with confirmed virologic breakthrough
| Estimated Enrollment: | 100 |
| Study Start Date: | September 2012 |
| Estimated Study Completion Date: | March 2018 |
| Estimated Primary Completion Date: | July 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Tenofovir DF
Tenofovir disoproxil fumarate oral tablet / oral powder
|
Drug: Tenofovir DF
Tenofovir disoproxil fumarate oral tablet / oral powder • subjects ≥ 17 kg: one tablet once daily (150, 200, 250 or 300 mg tablets based on body weight) or oral powder if unable to swallow a tablet. Other Names:
|
| Placebo Comparator: Tenofovir DF Placebo |
Drug: Tenofovir DF Placebo
Matching placebo oral tablet / oral powder
Other Names:
|
Eligibility| Ages Eligible for Study: | 2 Years to 11 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Male or Female, 2 to <12 years of age
- Weight ≥ 10kg
- Chronic HBV infection ≥ 6 months
- HBeAg-positive or HBeAg-negative
- HBV Viral Load ≥ 100,000 copies/mL
- ALT ≥ 1.5 x ULN at screening
- Creatinine Clearance ≥ 80mL/min
- ANC ≥ 1,500/mm^3, hemoglobin ≥ 10g/dL
- Negative pregnancy test at screening
- No prior tenofovir DF therapy (subjects may have received prior interferon‑alfa and/or other oral anti‑HBV nucleoside/nucleotide therapy; subjects must have discontinued interferon-alfa therapy ≥ 6 months prior to screening; subjects experienced on other anti-HBV nucleoside/nucleotide therapy must have discontinued therapy ≥ 16 weeks prior to screening to avoid flare if randomized to the placebo arm)
Exclusion Criteria:
- Pregnant or lactating
- Decompensated liver disease
- Received interferon therapy within 6 months of Screening
- Received anti-HBV nucleoside/nucleotide therapy within 16 weeks of Screening
- Alpha-fetoprotein levels > 50ng/mL
- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HIV, acute HAV, HCV, or HDV
- Chronic liver disease not due to HBV
- History of significant renal, cardiovascular, pulmonary, neurological or bone disease
- Long term non-steroidal, anti-inflammatory drug therapy
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01651403
Contacts
| Contact: Sandy Lee | Sandy.Lee@gilead.com |
Locations
| United States, New York | |
| New York School of Medicine | Recruiting |
| New York, New York, United States, 10016 | |
| Contact 212-263-8197 | |
| United States, Texas | |
| Texas Children's Hospital | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact 832-822-3606 | |
| Bulgaria | |
| University Multiprofile Hospital for Active Treatment "Sveti Georgi" | Recruiting |
| Plodiv, Bulgaria, 4002 | |
| Contact +35932602547 | |
| Multiprofile Hospital for Active Treatment "Tokuda Hospital" | Recruiting |
| Sofia, Bulgaria, 1407 | |
| Contact +00359884933064 | |
| Korea, Republic of | |
| Kyungpook National University | Recruiting |
| Daegu, Korea, Republic of, 700-721 | |
| Contact 82-103-008-5718 | |
| Gachon University Gil Hospital, Department of Pediatrics | Recruiting |
| Incheon, Korea, Republic of, 405-760 | |
| Contact +821037409464 | |
| Severance Children's Hospital | Recruiting |
| Seoul, Korea, Republic of, 120-752 | |
| Contact 822-222-8205 | |
| Pusan National University Yangsan Hospital | Recruiting |
| Yangsan-si, Korea, Republic of, 626 770 | |
| Contact +82 553-603-153 | |
| Romania | |
| National Institute of Infectious Diseases | Recruiting |
| Bucharest, Romania, 021105 | |
| Contact 40-21-318-6100 | |
| Fundeni Clinical Institute - Constantinesco | Recruiting |
| Bucharest, Romania, 022328 | |
| Contact +40 72 174 2134 | |
| Grigore Alexandrescu Emergency Clinical Hospital for Children | Recruiting |
| Bucharest, Romania, 011743 | |
| Contact +40 722 409527 | |
| Clinical Infectious Diseases Hospital of Constanta | Recruiting |
| Constanta, Romania, 900708 | |
| Contact +40 241 617 890 | |
| "Victor Babes" Clinical Hospital of Infectious Diseases and Pneumophtisology | Recruiting |
| Craiova, Romania, 200515 | |
| Contact: Gheorghe Lulian Diaconescu, MD +0040721334400 | |
| Taiwan | |
| Taipei Veterans General Hospital | Recruiting |
| Taipei, Taiwan, 11217 | |
| Contact 01188633281200 | |
Sponsors and Collaborators
Gilead Sciences
Investigators
| Study Director: | Bittoo Kanwar, MD | Gilead Sciences |
More Information
No publications provided
| Responsible Party: | Gilead Sciences |
| ClinicalTrials.gov Identifier: | NCT01651403 History of Changes |
| Other Study ID Numbers: | GS-US-174-0144 |
| Study First Received: | July 25, 2012 |
| Last Updated: | June 5, 2013 |
| Health Authority: | United States: Food and Drug Administration Bulgaria: European Medicines Agency (EMA), Bulgarian Drug Agency India: Drugs Controller General of India Poland: EMA, Central Register of Clinical Trials Romania: EMA, National Medicines Agency South Korea: Korea Food and Drug Administration (KFDA) Taiwan: Taiwan Food and Drug Administration (TFDA) |
Keywords provided by Gilead Sciences:
|
Hepatitis Hepatitis B HBV |
Additional relevant MeSH terms:
|
Hepatitis Hepatitis A Hepatitis B Hepatitis, Chronic Hepatitis B, Chronic Hepatitis, Viral, Human Liver Diseases Digestive System Diseases Virus Diseases Enterovirus Infections Picornaviridae Infections RNA Virus Infections Hepadnaviridae Infections |
DNA Virus Infections Tenofovir Tenofovir disoproxil Reverse Transcriptase Inhibitors Nucleic Acid Synthesis Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Pharmacologic Actions Anti-Retroviral Agents Antiviral Agents Anti-Infective Agents Therapeutic Uses Anti-HIV Agents |
ClinicalTrials.gov processed this record on June 17, 2013