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The purpose of this study is to evaluate the antiviral activity and safety of tenofovir disoproxil fumarate (TDF) in Asian-American adults (self-reported Asian descent, living in the United States) with chronic hepatitis B infection. All participants will receive active treatment with TDF for 48 weeks.
Efficacy of TDF will be evaluated for reductions in serum HBV DNA, changes in liver enzymes, and the generation of antibody to the virus. Safety will be assessed by evaluating adverse events, laboratory abnormalities, and the development of drug resistance mutations.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TDF | Experimental | 300-mg tablet (marketed formulation) taken orally once daily |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tenofovir disoproxil fumarate | Drug | 300-mg tablet (marketed formulation) taken orally once daily |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) | Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method. | Week 48 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48 | Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48 | Week 48 |
| Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48 |
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Inclusion Criteria:
Exclusion Criteria:
Participants who meet any of the following exclusion criteria are not to be enrolled in this study.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fountain Valley | California | 92708 | United States | |||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25987775 | Derived | Pan CQ, Chan S, Trinh H, Yao A, Bae H, Lou L. Similar efficacy and safety of tenofovir in Asians and non-Asians with chronic hepatitis B. World J Gastroenterol. 2015 May 14;21(18):5524-31. doi: 10.3748/wjg.v21.i18.5524. | |
| 24594870 | Derived | Pan CQ, Trinh H, Yao A, Bae H, Lou L, Chan S; Study 123 Group. Efficacy and safety of tenofovir disoproxil fumarate in Asian-Americans with chronic hepatitis B in community settings. PLoS One. 2014 Mar 4;9(3):e89789. doi: 10.1371/journal.pone.0089789. eCollection 2014. |
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| ID | Title | Description |
|---|---|---|
| FG000 | A: TDF | Tenofovir disoproxil fumarate (TDF) 300 mg by mouth daily |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L) |
| Week 48 |
| Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48 | Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | Week 48 |
| Change From Baseline in FibroTest Value | The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. | Baseline and Week 48 |
| Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion | HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48. | Week 48 |
| Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48 | Blood samples from study participants were collected for measuring HBV DNA via PCR method. | Week 48 |
| Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss | Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | Week 48 |
| Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe | Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | Week 48 |
| Summary of Resistance Surveillance for Participants Without Virologic Breakthrough | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | Week 48 |
| Summary of Resistance Surveillance for Participants With Virologic Breakthrough | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | Week 48 |
| Summary of Resistance Surveillance for Participants Who Discontinued the Study Early | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | Week 48 |
| Hacienda Heights |
| California |
| 91745 |
| United States |
| Los Angeles | California | 90057 | United States |
| Monterey Park | California | 91754 | United States |
| Mountain View | California | 94040 | United States |
| Oakland | California | 94609 | United States |
| Palo Alto | California | 94304 | United States |
| San Jose | California | 95128 | United States |
| Hamden | Connecticut | 06518 | United States |
| Baltimore | Maryland | 21234 | United States |
| Laurel | Maryland | 20707 | United States |
| Silver Spring | Maryland | 20902 | United States |
| Englewood | New Jersey | 07631 | United States |
| Brooklyn | New York | 11219 | United States |
| Flushing | New York | 11355 | United States |
| New York | New York | 10013 | United States |
| New York | New York | 10038 | United States |
| Philadelphia | Pennsylvania | 19107 | United States |
| Fairfax | Virginia | 22030 | United States |
| Falls Church | Virginia | 22044 | United States |
| Bellevue | Washington | 98004 | United States |
| COMPLETED |
|
| NOT COMPLETED |
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| ID | Title | Description |
|---|---|---|
| BG000 | A: TDF | Tenofovir disoproxil fumarate 300 mg by mouth daily |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Standard Deviation | years |
| ||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| |||||||||||||||||||||||
| Region of Enrollment | Number | participants |
| |||||||||||||||||||||||
| Ethnicity | Number | Participants |
| |||||||||||||||||||||||
| Hepatitis B virus (HBV) deoxyribonucleic acid (DNA) | Plasma HBV DNA was analyzed using polymerase chain reaction (PCR) method. | Mean | Standard Deviation | log10 copies/mL |
| |||||||||||||||||||||
| Hepatitis B e antigen (HBeAg) | Blood samples were collected for HBV serology. | Number | Participants |
| ||||||||||||||||||||||
| Antibody to HBeAg (Anti-HBe) | Blood samples were collected for HBV serology. | Number | Participants |
| ||||||||||||||||||||||
| Positive Hepatitis B surface antigen (HBsAg) | Blood samples were collected for HBV serology. | Number | Participants |
| ||||||||||||||||||||||
| Alanine aminotransferase (ALT); upper limit of normal (ULN) = 34 U/L | Blood samples were collected for serum chemistry. | Mean | Standard Deviation | U/L |
| |||||||||||||||||||||
| ALT (Multiples of ULN) | Blood samples were collected for serum chemistry. Multiples are based on ULN of 34 U/L. | Mean | Standard Deviation | multiples of ULN |
| |||||||||||||||||||||
| ALT | Blood samples were collected for serum chemistry. The ULN for ALT was 34 U/L. | Number | Participants |
| ||||||||||||||||||||||
| HBV genotype | Genotypic analysis was conducted at baseline for all participants. | Number | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Number of Participants With Hepatitis B Virus (HBV) Deoxyribonucleic Acid (DNA) <400 Copies/mL (<69 IU/mL) | Blood samples were collected from study participants for measuring HBV DNA via polymerase chain reaction (PCR) method. | The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With Alanine Aminotransferase (ALT) Normal at Week 48 | Number of participants with normal ALT (at or below the upper limit of normal [ULN] for the central laboratory [34 U/L])at Week 48 | The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With ALT Normalized (Baseline Values > ULN [34 U/L] and <= ULN at a Subsequent Visit) at Week 48 | A normal value at Week 48 after having elevated ALT at baseline; normal ALT is defined as being at or below the ULN for the central laboratory (34 U/L) | The enrolled-and-treated analysis set included participants who were enrolled into the study, received at least one dose of study drug, and had baseline ALT > ULN (34 U/L). | Posted | Number | participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite Endpoint of Hepatitis B Virus (HBV) DNA <400 Copies/mL (<69 IU/mL) and Normal ALT at Week 48 | Blood samples were collected for evaluating serum chemistry, including determination of ALT, and for measuring HBV DNA via PCR method. Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost hepatitis B e antigen (HBeAg) or developed antibody to hepatitis B e antigen (anti-HBe), only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Change From Baseline in FibroTest Value | The FibroTest score is used to assess liver fibrosis and is calculated based on a formula including the participant's age and sex and 5 laboratory parameters: alpha 2 macroglobulin, haptoglobin, gamma-glutamyl transferase (GGT), bilirubin, and apolipoprotein A1. Scores can range from 0.00 to 1.00, with higher scores indicating a greater degree of fibrosis. | The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug. | Posted | Mean | Standard Deviation | Scores on a scale | Baseline and Week 48 |
|
| ||||||||||||||||||||||||||
| Secondary | Number of Participants With HBeAg/Hepatitis B Surface Antigen (HBsAg) Loss and Seroconversion | HBeAg/HBsAg loss is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- at Week 48. HBeAg/HBsAg serocoversion is defined for an individual participant as HBeAg+/HBsAg+ at baseline and HBeAg-/HBsAg- and anti-HBe+/antibody to hepatitis B surface antigen+ (anti-HBs+) at Week 48. | Posted | Number | Participants | Week 48 |
|
| ||||||||||||||||||||||||||||
| Secondary | Number of Participants With HBV DNA < 169 Copies/mL (<29 IU/mL) at Week 48 | Blood samples from study participants were collected for measuring HBV DNA via PCR method. | The enrolled-and-treated analysis set included participants who were enrolled into the study and received at least one dose of study drug. | Posted | Number | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and HBeAg Loss | Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN [34 U/L]); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | Not Posted | Jan 2099 | Number | Participants | Week 48 | |||||||||||||||||||||||||||||
| Secondary | Number of Participants With Composite Endpoint of HBV DNA <400 Copies/mL (<69 IU/mL), Normal ALT, and Seroconversion to Anti-HBe | Composite endpoints proposed in the protocol included the percentage of participants with HBV DNA < 400 copies/mL (<69 IU/mL) and normal ALT (ALT <= ULN); and with HBV DNA < 400 copies/mL, normal ALT, and HBeAg loss/seroconversion. Because so few participants lost HBeAg or seroconverted to anti-HBe, only the composite endpoint of HBV DNA < 400 copies/mL and normal ALT was analyzed. | Not Posted | Jan 2099 | Participants | Week 48 | ||||||||||||||||||||||||||||||
| Secondary | Summary of Resistance Surveillance for Participants Without Virologic Breakthrough | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | 10 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and did not have virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir). | Posted | Number | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Summary of Resistance Surveillance for Participants With Virologic Breakthrough | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | 2 participants received >= 1 dose of study drug, remained viremic (HBV DNA >= 400 copies/mL) after 48 weeks of TDF treatment, had serum sample for testing, and had virologic breakthrough (defined as HBV DNA >= 400 copies/mL [confirmed] after having HBV DNA levels < 400 copies/mL and/or 1-log10 increase [confirmed] in HBV DNA above nadir). | Posted | Number | Participants | Week 48 |
|
| |||||||||||||||||||||||||||
| Secondary | Summary of Resistance Surveillance for Participants Who Discontinued the Study Early | Serum was collected for HBV resistance surveillance, and sequence analysis of the HBV polymerase was assessed through di-deoxy sequencing of baseline and postbaseline samples. | 2 participants received >= 1 dose of study drug, discontinued TDF treatment after Week 24 with HBV DNA >= 400 copies/mL, and had serum sample for testing. | Posted | Number | Participants | Week 48 |
|
|
48 weeks + the follow-up off-study medication period (if applicable). Participants who permanently discontinued study drug were to be followed for 24 weeks off treatment or up to initiation of active treatment, whichever occurred first.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: TDF | Tenofovir disoproxil fumarate 300 mg by mouth daily | 1 | 90 | 27 | 90 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Hepatic neoplasm malignant | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA 11.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nasopharyngitis | Infections and infestations | MedDRA (11.0) | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA (11.0) | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA (11.0) | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (11.0) | Systematic Assessment |
|
Investigators may discuss or publish results (without Gilead's confidential information) after all results have been publicly disclosed by/with consent of Gilead or study has been completed >=2 years. Proposed publication/presentation and destination details must be submitted >=30 days before submission. The investigator agrees to withhold publication or presentation for an additional 60 days in order to obtain patent protection if deemed necessary.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eduardo Bruno Martins, MD, DPhil, Sr. Director, Medical Affairs - Hepatitis | Gilead Sciences, Inc. | 650-522-5792 | eduardo.martins@gilead.com |
| ID | Term |
|---|---|
| D019694 | Hepatitis B, Chronic |
| D006509 | Hepatitis B |
| D006505 | Hepatitis |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006521 | Hepatitis, Chronic |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
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| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian-Vietnamese |
|
| Asian-Cambodian |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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|
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
| HBsAg+ at baseline |
| |||||
| HBsAg- at baseline |
| |||||
| HBsAg+ at Week 48 |
| |||||
| HBsAg data missing at Week 48 |
| |||||
| HBeAg+ at baseline |
| |||||
| HBeAg- at baseline |
| |||||
| HBeAg loss by Week 48 |
| |||||
| Anti-HBe+ seroconversion by Week 48 |
|
| Title | Denominators | Categories | ||||
|---|---|---|---|---|---|---|
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