Chronic Hepatitis BNCT01267162
Long-term Study on Anti-HBV Effect of Tenofovir and Resistance Surveillance in Asian-American Adult Patients
An observational study of Chronic Hepatitis B, run by Medical Procare PLLC at 5 sites in United States.
Trial summary
This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Hepatitis B
- How many people
- 31 participants
- Where
- 5 sitesUnited States
- Study dates
- Sep 2010to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: adult infected with chronic hepatitis B
Who may be able to join
- Male or female, Asian-American, who have participated and completed the study, qualify the following criteria, and remain on TDF treatment without severe treatment-related AEs, and with available retrospective lab results as summarized in Appendix 2.
- 18 through 75 years of age, inclusive
- Willing to participate in the present study and able to provide written informed consent
- Continuation of HBV treatment is indicated. That is for HBeAg-positive subjects, HBeAg remain positive or HBeAg becomes negative but still has detectable DNA by the PCR method; and for HBeAg-negative subjects, HBV DNA is either detectable or undetectable by the PCR method
- No clinical or virologic evidence of anti-HBV resistance to TDF treatment at the time of entering tests (i.e., TDF treatment week 48 lab tests by the 123 study)
- Estimated glomerular filtration rate (creatinine clearance) ≥ 60 mL/min/1.73m2 by the
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- Cockcroft-Gault equation:
- (140-age in years) (body weight [kg]) (72) (serum creatinine [mg/dl]) [Note: multiply estimated rate 0. by 85 for women; use actual body weight]
- Adequate hematologic function (absolute neutrophil count ≥ 1,500/mm3; hemoglobin ≥ 10.0 g/dL)
Who cannot join
- Pregnant women, and women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
- Willing and able to provide written informed consent
- Decompensated liver disease defined as direct (conjugated) bilirubin ≥ 1.2 ULN; PT ≥ 1.2 ULN, platelets ≤ 150,000/mm3, or serum albumin ≤ 3.5 g/dL
- Prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy) or variceal hemorrhage
- Serum α-fetoprotein ≥ 50 ng/mL
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- Evidence of hepatocellular carcinoma (HCC)
- Co-infection with HIV, HCV, or HDV
- History of significant renal disease (e.g., nephrotic syndrome, renal dysgenesis, polycystic kidney disease, congenital nephrosis, acute tubular necrosis, other renal disease)
- History of significant bone disease (e.g., osteomalacia, chronic osteomyelitis, osteogenesis imperfecta, osteochondroses, multiple bone fractures)
- Significant cardiovascular, pulmonary or neurological disease
- Evidence of a gastrointestinal malabsorption syndrome that may interfere with absorption of orally administered medications
- History of solid organ or bone marrow transplantation
- Ongoing therapy with any of the following: Nephrotoxic agents
- Parenteral aminoglycoside antibiotics (e.g., gentamicin, tobramycin, amikacin)
- Cidofovir
- Cisplatin
- Foscarnet
- IV amphotericin B
- IV pentamidine
- Oral or IV ganciclovir
- Cyclosporine
- Tacrolimus
- IV vancomycin
- Chronic daily non-steroidal anti-inflammatory drug therapy
- Competitors of renal excretion (e.g., probenecid) Systemic chemotherapeutic agents
- Systemic corticosteroids
- Interleukin-2 (IL-2) and other immunomodulating agents
- Investigational agents (except with the expressed approval of the lead investigators) Administration of any of the above medications must be discontinued at least 30 days prior to the Baseline Visit and for the duration of the study period.
- Known hypersensitivity to the study drugs, the metabolites or formulation excipients
- Any other condition (including alcohol or substance abuse) or prior therapy that, in the opinion of the Investigators, would make the subject unsuitable for the study or unable to comply with dosing requirements
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Dreamworks Endoscopy
Flushing, New York, 11354
Dr. Calvin Pan's Flushing Office
Flushing, Queens, New York, 11355
Asian Pacific Liver Center of St. Vincent Medical Center
Los Angeles, California, 90057
Xiaoli Ma, PC
Philadelphia, Pennsylvania, 19107
San Jose Gastroenterology
San Jose, California, 95128
About this study
Official title: Long-term Observational Study on Anti-HBV Effect of Tenofovir Disoproxil Fumarate (TDF) and Resistance Surveillance in Asian-American Adult Patients Formerly Participating Gilead 123 Studies
This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. The primary objective of this study is to evaluate the long-term antiviral efficacy of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate the safety and tolerability of TDF including the biochemical and virological responses to TDF, the incidence of drug resistance mutations in these patients The duration of treatment in this study is total of three Years (144 weeks) on TDF.
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB
- Medical subject headings
- Hepatitis B, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| TDF Treatment | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
HBV DNA suppression
Measured: in three years
safety use of TDF
including elevation of creatine or decrease in GFR, TDF resistance
Measured: in three years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2010 (estimated)
- Study startSep 2010
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis BStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical Procare PLLC
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01267162
- Sponsor's protocol ID
- IN-US-174-0156
- Status last verified
- Mar 2016
- First submitted
- 23 Dec 2010
- Last updated
- 16 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long-term Observational Study on Anti-HBV Effect of Tenofovir Disoproxil Fumarate (TDF) and Resistance Surveillance in Asian-American Adult Patients Formerly Participating Gilead 123 Studies
- ClinicalTrials.gov ID
- NCT01267162
- Acronym / sponsor ID
- IN-US-174-0156
- Conditions
- Chronic Hepatitis B
- Keywords
- CHB
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Medical Procare PLLCUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 28 Dec 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a Phase IV, open-label, single-arm, 96 week community-based observational study evaluating the antiviral efficacy, safety, and tolerability of TDF in HBV mono-infected Asian-American adults who had completed 48 week treatment with Tenofovir in Gilead 174-0123 study. The primary objective of this study is to evaluate the long-term antiviral efficacy of tenofovir DF 300 mg once daily in these patients. The secondary objectives are to evaluate the safety and tolerability of TDF including the biochemical and virological responses to TDF, the incidence of drug resistance mutations in these patients The duration of treatment in this study is total of three Years (144 weeks) on TDF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TDF Treatment | – | – |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult infected with chronic hepatitis B
Key inclusion criteria (9 listed)
- Male or female, Asian-American, who have participated and completed the study, qualify the following criteria, and remain on TDF treatment without severe treatment-related AEs, and with available retrospective lab results as summarized in Appendix 2.
- 18 through 75 years of age, inclusive
- Willing to participate in the present study and able to provide written informed consent
- Continuation of HBV treatment is indicated. That is for HBeAg-positive subjects, HBeAg remain positive or HBeAg becomes negative but still has detectable DNA by the PCR method; and for HBeAg-negative subjects, HBV DNA is either detectable or undetectable by the PCR method
- No clinical or virologic evidence of anti-HBV resistance to TDF treatment at the time of entering tests (i.e., TDF treatment week 48 lab tests by the 123 study)
Key exclusion criteria (31 listed)
- Pregnant women, and women who are breast feeding or who believe they may wish to become pregnant during the course of the study.
- Males and females of reproductive potential who are not willing to use an effective method of contraception during the study. For males, condoms should be used and for females, a barrier contraception method should be used in combination with one other form of contraception.
- Willing and able to provide written informed consent
- Decompensated liver disease defined as direct (conjugated) bilirubin ≥ 1.2 ULN; PT ≥ 1.2 ULN, platelets ≤ 150,000/mm3, or serum albumin ≤ 3.5 g/dL
- Prior history of clinical hepatic decompensation (e.g., ascites, jaundice, encephalopathy) or variceal hemorrhage
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
HBV DNA suppression
Time frame: in three years
safety use of TDF
Time frame: in three years
including elevation of creatine or decrease in GFR, TDF resistance
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Hepatitis B, run by Medical Procare PLLC at 5 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 31 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
HBV DNA suppression (time frame: in three years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Mar 2016.