Hepatitis C InfectionNCT01465516
Treating Hispanic Patients Diagnosed With Hepatitis C Using Boceprevir
An observational study of Hepatitis C Infection, run by Arrowhead Regional Medical Center at 1 site in United States.
Trial summary
Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Hepatitis C Infection
- What is being tested?
- Boceprevir
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2011to Dec 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Hispanic patients >18 years of age with cirrhosis or bridging fibrosis with Hepatitis C Infection whom are treatment naive.
Who may be able to join
- To be eligible for this trial, patients must have documentation of the following:
- Male or female > 18 years old
- HCV genotype-1 infection
- Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years
- No previous treatment with any anti-HCV therapy (approved or investigational)
- For women of childbearing potential, a negative urine pregnancy test result documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during study treatment and for 6 months after treatment.
- Willingness to give written informed consent and to participate in and comply with requirements of the study
Who cannot join
- Patients with any of the following will not be eligible for participation:
- Infection with HCV other than genotype 1
- History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History or other evidence of decompensated liver disease (e.g., coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from esophageal varices) or a Child-Pugh score > 6 (see Appendix 1)
- Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM) antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab, or anti-HIV antibodies
- History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against HCV within 3 months prior to enrollment.
Show all 20Show fewer
- Pregnant or breastfeeding
- Male partners of females who are pregnant or breastfeeding
- Hemoglobin concentration < 12 g/dL in females or < 13 g/dL in males or any patient with an increased risk for anemia (e.g., thalassemia, sickle cell anemia, spherocytosis, history of gastrointestinal bleeding) or for whom anemia would be medically problematic
- Absolute neutrophil count (ANC) < 1000 cells/mm3
- Platelet count < 70,000 cells/mm3
- Receipt of stimulating factors such as granulocyte colony stimulating factor (G-CSF), erythropoietin, or other therapeutic agents to elevate hematology parameters to facilitate patient entry into the study
- Serum creatinine concentration > 1.5 times the upper limit of normal (ULN)
- History of severe psychiatric disease, including psychosis and/or depression, characterized by a suicide attempt, hospitalization for psychiatric disease, or a period of disability as a result of psychiatric disease
- Poorly controlled thyroid dysfunction
- History of cardiac disease (e.g., New York Heart Association functional class II, III, or IV, myocardial infarction within the last 6 months, ventricular tachyarrhythmias requiring ongoing treatment, unstable angina, or other significant cardiovascular diseases. In addition, patients with documented or presumed coronary artery disease or cerebrovascular disease should not be enrolled if, in the judgment of the investigator, an acute decrease in hemoglobin by up to 4 g/dL (as may be seen with ribavirin therapy) would not be well tolerated.
- History of uncontrolled severe seizure disorder within the last year
- Patients treated previously with protease or polymerase inhibitors
- Coadministration of drugs that are highly dependent on CYP3A4/5 for clearance, and for which elevated plasma concentrations are associated with serious and/or life-threatening events including those in Appendix 2.
- Coadministration with potent CYP3A4/5 inducers, where significantly reduced boceprevir plasma concentrations may be associated with reduced efficacy.
Trial locations and contacts
1 site in 1 country.
United States1 site
Southern California Transplantation Institute Research Foundation
Riverside, California, 92501
About this study
Official title: Response Guided Therapy (RGT) for Boceprevir Combined With Peginterferon Alpha-2b Plus Ribavirin in Naïve Hispanic Patients With Genotype 1 Hepatitis C Infection
Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.
Read the detailed description
STUDY DESIGN AND ENROLLMENT Open label single arm pilot study enrolling Hispanic patients with HCV genotype 1 and naive to pegylated interferon and BOC treatment.
Definition of BOC RGT:
All patients will receive 4 weeks of PR (lead-in), and BOC will be added at the beginning of week 5. Patients who have an undetectable HCV RNA at week 8 and week 24 will receive 24 weeks of PR and BOC (28 weeks total treatment); patients who have a detectable HCV RNA at week 8, but an undetectable HCV RNA at week 24, will receive an additional 32 weeks of PR and BOC, followed by 12 weeks of PR (48 weeks total treatment).
Patients with cirrhosis or bridging fibrosis (Stage 4 fibrosis) will receive 4 weeks of lead in followed by 44 weeks of BOC and PR (total 48 weeks).
- Conditions
- Hepatitis C Infection
- Being tested
- Boceprevir
- Medical subject headings
- Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BoceprevirDrug
Also called Victrelis
Baseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin).
Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results
| Study group | Role | What they receive |
|---|---|---|
| Hispanic, HCV genotype 1 | Historical group will be a continuous group of Hispanic patients with genotype 1 who were naive to treatment and completed or initiated 48 weeks of pegylated interferon and ribavirin. Patients, who discontinued the treatment due to side effects, adherence issues, or treatment failure, will be included and analyzed based on intention to treat analysis. All patients will be stratified according to their SVR, relapse and no response rate. RVR, EVR, and ETR will be also collated and compared to the study group. Receives: Drug: Boceprevir |
What is being measured
The primary outcome is the main question the study is designed to answer.
SVR based on intention to treat analysis
Patients who have detectable HCV RNA at week 24 must have study treatment discontinued.
Measured: 24 weeks
Secondary outcomes (2)
Tolerance
All patients who have study treatment discontinued should have the assessments scheduled for the end of anti HCV treatment (Week 48) performed at the time of premature discontinuation and the follow-up assessments required 12 weeks after the end of anti HCV therapy.
If a discontinued patient received greater than or equal to 12 weeks of anti HCV therapy, an HCV test should be performed 24 weeks after the last dose of anti HCV treatment.
Measured: 48 weeks
BDI II score 31 or above
Any patient who has a BDI II score greater than or equal to 31 at any time during the study should have study treatment discontinued.
Measured: 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startNov 2011
- Primary completionDec 2013
- Study completionDec 2013
Why it stopped: The study was terminated and recruitment was capped because of the new changes in hepatitis C market
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis C InfectionStudies 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
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Arrowhead Regional Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zeid Kayali, MD, Arrowhead Regional Medical Center
- Investigators
- Zeid Kayali, MD, Principal investigator, Southern California Transplantation Institute Research Foundation
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465516
- Sponsor's protocol ID
- 38950
- Status last verified
- Jun 2015
- First submitted
- 2 Nov 2011
- Last updated
- 30 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Response Guided Therapy (RGT) for Boceprevir Combined With Peginterferon Alpha-2b Plus Ribavirin in Naïve Hispanic Patients With Genotype 1 Hepatitis C Infection
- ClinicalTrials.gov ID
- NCT01465516
- Acronym / sponsor ID
- 38950
- Conditions
- Hepatitis C Infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: The study was terminated and recruitment was capped because of the new changes in hepatitis C market
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Arrowhead Regional Medical CenterUniversity, hospital or other
- Study start
- Nov 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 4 Nov 2011 (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.
Hypothesis Response guided therapy improves significantly the overall SVR in Hispanics compared to historical control. There is no difference in SVR between patients with an undetectable HCV RNA at week 8 and week 28 who received a 4 week lead-in of PR plus 24 weeks of PR+BOC based treatment and patients with detectable HCV RNA at week 8 and undetectable HCV RNA at week 24 who received a lead-in of PR plus 32 weeks PR+BOC followed by based therapy and 12 weeks of PR.
Detailed description
STUDY DESIGN AND ENROLLMENT Open label single arm pilot study enrolling Hispanic patients with HCV genotype 1 and naive to pegylated interferon and BOC treatment.
Definition of BOC RGT:
All patients will receive 4 weeks of PR (lead-in), and BOC will be added at the beginning of week 5. Patients who have an undetectable HCV RNA at week 8 and week 24 will receive 24 weeks of PR and BOC (28 weeks total treatment); patients who have a detectable HCV RNA at week 8, but an undetectable HCV RNA at week 24, will receive an additional 32 weeks of PR and BOC, followed by 12 weeks of PR (48 weeks total treatment).
Patients with cirrhosis or bridging fibrosis (Stage 4 fibrosis) will receive 4 weeks of lead in followed by 44 weeks of BOC and PR (total 48 weeks).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hispanic, HCV genotype 1 | – | Drug: BoceprevirHistorical group will be a continuous group of Hispanic patients with genotype 1 who were naive to treatment and completed or initiated 48 weeks of pegylated interferon and ribavirin. Patients, who discontinued the treatment due to side effects, adherence issues, or treatment failure, will be included and analyzed based on intention to treat analysis. All patients will be stratified according to their SVR, relapse and no response rate. RVR, EVR, and ETR will be also collated and compared to the study group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Hispanic patients >18 years of age with cirrhosis or bridging fibrosis with Hepatitis C Infection whom are treatment naive.
Key inclusion criteria (7 listed)
- Male or female > 18 years old
- HCV genotype-1 infection
- Liver biopsy consistent with Chronic Hepatitis C (CHC) within the last 3 years
- No previous treatment with any anti-HCV therapy (approved or investigational)
- For women of childbearing potential, a negative urine pregnancy test result documented within 24 hours prior to the first dose of any study drug (BOC, PEG-INF alfa-2b, or ribavirin). Additionally, all female patients of childbearing potential and all males with female partners of childbearing potential must use two forms of effective contraception (combined) during study treatment and for 6 months after treatment.
Key exclusion criteria (20 listed)
- Infection with HCV other than genotype 1
- History or other evidence of a medical condition associated with chronic liver disease other than CHC (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- History or other evidence of decompensated liver disease (e.g., coagulopathy, hyperbilirubinemia, hepatic encephalopathy, hypoalbuminemia, ascites, bleeding from esophageal varices) or a Child-Pugh score > 6 (see Appendix 1)
- Infection with hepatitis A virus (HAV), hepatitis B virus (HBV), or HIV as demonstrated by a positive test at screening for anti-HAV immunoglobulin M (IgM) antibodies (Ab), hepatitis B surface antigen, anti-hepatitis B core protein IgM Ab, or anti-HIV antibodies
- History of having received IFN, PEG-IFN, ribavirin, viramidine, levovirin, or investigational HCV protease or polymerase inhibitors at any previous time, or any other systemic antiviral therapy with established or perceived activity against HCV within 3 months prior to enrollment.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BoceprevirAlso: VictrelisBaseline assessments must be obtained on the day of or prior to enrollment and prior to administration of the first dose of any study drug (BOC, PEG-IFN alfa-2b, or ribavirin). Using the RGT guidelines in patients who are previously untreated: all patients will receive a lead-in treatment of PR for 4 weeks, then BOC will be added to PR for 4 weeks; based on patient's week 8 HCV RNA results | Drug | Hispanic, HCV genotype 1 |
Primary outcome
SVR based on intention to treat analysis
Time frame: 24 weeks
Patients who have detectable HCV RNA at week 24 must have study treatment discontinued.
2 secondary outcomes
Tolerance
Time frame: 48 weeks
BDI II score 31 or above
Time frame: 48 weeks
Results and safety
The study was stopped early (reason given: The study was terminated and recruitment was capped because of the new changes in hepatitis C market). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2015.
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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.
Zeid Kayali, MD principal investigator
Southern California Transplantation Institute Research Foundation
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hepatitis C Infection, run by Arrowhead Regional Medical Center at 1 site 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 7 inclusion and 20 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: stopped early, as of the sponsor's last update on 30 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 was stopped early (reason given: The study was terminated and recruitment was capped because of the new changes in hepatitis C market). Results are not available in the source record.
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?
SVR based on intention to treat analysis (time frame: 24 weeks). 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 30 Jun 2015.