Chronic Hepatitis CPhase 4PBMCNCT00680173
Peripheral Blood Mononuclear Cell (PBMC) Gene Expression in HCV Genotype 1 Patients
A Phase 4 study testing pegylated interferon alpha 2a and plus ribavirin in people with Chronic Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
Trial summary
Our previous collaborative studies has developed a molecular diagnosis tool, which is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients prior to treatment. Aims of this project: 1. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- pegylated interferon alpha 2a and plus ribavirin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2006to Mar 2016
- Phase
- Phase 4
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male and female patients >18 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
- Compensated liver disease (Child-Pugh Grade A clinical classification)
- Negative urine or blood pregnancy test (for women of childbearing potential) documented within the 24-hour period prior to the first dose of study drug
- All fertile males and females receiving ribavirin must be using two forms of effective contraception during treatment and during the 6 months after treatment end
Who cannot join
- Women with ongoing pregnancy or breast feeding
- Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
- Clinical evidence of hepatocellular carcinoma
Show all 22Show fewer
- History or other evidence of bleeding from esophageal varices or other conditions consistent with decompensated liver disease
- Neutrophil count <1500 cells/mm3 or platelet count <90,000 cells/mm3 at screening
- Serum creatinine level >1.5 times the upper limit of normal at screening
- History of severe psychiatric disease, especially depression. Severe psychiatric disease is defined as treatment with an antidepressant medication or a major tranquilizer at therapeutic doses for major depression or psychosis, respectively, for at least 3 months at any previous time or any history of the following: a suicidal attempt, hospitalization for psychiatric disease, or a period of disability due to a psychiatric disease
- History of a severe seizure disorder or current anticonvulsant use
- History of immunologically mediated disease, chronic pulmonary disease associated with functional limitation, severe cardiac disease, major organ transplantation or other evidence of severe illness, or any other conditions which would make the patient, in the opinion of the investigator, unsuitable for the study
- History of thyroid disease poorly controlled on prescribed medications, elevated thyroid stimulating hormone (TSH) concentrations with elevation of antibodies to thyroid peroxidase and any clinical manifestations of thyroid disease
- Evidence of severe retinopathy (e.g. CMV retinitis, macula degeneration)
- Evidence of drug abuse (including excessive alcohol consumption>40 g/day) within one year of study entry
- Inability or unwillingness to provide informed consent or abide by the requirements of the study
- Male partners of women who are pregnant
- Hgb <11 g/dL in women or <12 g/dL in men at screening
- Any patient with major thalassemia
- 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
- Evidence or history of hepatocellular carcinoma
- Local or Systemic malignancy unstable status
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analysis of Gene Expression of PBMC in the Hepatitis C Virus Genotype 1b-infected Patients During Peg-interferon-α Plus Ribavirin Combination Therapy
Our previous collaborative studies has developed a molecular diagnosis tool, which is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients prior to treatment.
Aims of this project:
- To analyze and validate the gene expression profiling dependent of treatment response to peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients.
- To select the candidate genes and establish a monitoring model assessing the efficacy of interferon treatment.
Read the detailed description
A combination of pegylated-interferon (PEG-IFN) with ribavirin has been the choice for treating chronic hepatitis C (CHC) patients. In addition to the high cost, the treatment takes 6 to 12 months and often brings significant adverse reactions to some patients. It would therefore be beneficial to include a pre-treatment evaluation and post-treatment monitoring system to maximize the efficacy of CHC therapy. We have established a molecular diagnosis tool for assessing the efficacy of interferon combined therapy for CHC patients prior to treatment. This diagnostic tool is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs) strongly associated with interferon efficacy in treating CHC patients. The prediction model has been validated by hepatitis C samples in Taiwan, and it achieved 80 % accuracy, higher than the current efficacy rates. Supplemented with the viral genotype information would further increase the prediction accuracy to 85%.
In this project, we aim to analyze patients' gene expression profiling during the treatment. The current study will focus on 30 PEG-IFN and ribavirin treated patients with HCV genotype 1 infection. After the responding status of those patients has been confirmed, we will compare gene expression profiling among the different responses before and during treatment. By using this information, we can properly select the candidate genes, and establish a monitoring model with these biomarkers. This monitoring model can thus be applied to assess the efficacy of PEG-IFN plus ribavirin combination treatment.
- Conditions
- Chronic Hepatitis C
- Being tested
- pegylated interferon alpha 2a and plus ribavirin
- Keywords
- Chronic Hepatitis C, Single nucleotide polymorphisms, Sustained virological response, Peginterferon, Ribavirin
- Medical subject headings
- Hepatitis C, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pegylated interferon alpha 2a and plus ribavirinDrug
Also called PEGASYS®
pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| A | Active comparator | 15 patients with HCV genotype 1 infection receiving peginterferon plus ribavirin achieve a sustained virological response Receives: Drug: pegylated interferon alpha 2a and plus ribavirin |
| B | Active comparator | 15 patients with HCV genotype 1 infection receiving peginterferon plus ribavirin did not achieve a sustained virological response Receives: Drug: pegylated interferon alpha 2a and plus ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Measured: 1.5 year
Secondary outcomes (3)
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Measured: 1.5 year
Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.
Measured: 1.5 year
Safety - adverse event rate and profile
Measured: 1.5 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2008 (estimated)
- Study startAug 2006
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Chronic Hepatitis CStudies of the same condition, open and under way.
- More trials run by Kaohsiung Medical University Chung-Ho Memorial HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wan-Long Chuang, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Wan-Long Chuang, MD, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00680173
- Sponsor's protocol ID
- KMUH-IRB- 950419
- Acronym
- PBMC
- Status last verified
- Mar 2016
- First submitted
- 15 May 2008
- Last updated
- 14 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Dai CY, Chuang WL, Hsieh MY, Lee LP, Hou NJ, Chen SC, Lin ZY, Hsieh MY, Wang LY, Tsai JF, Chang WY, Yu ML. Polymorphism of interferon-gamma gene at position +874 and clinical characteristics of chronic hepatitis C. Transl Res. 2006 Sep;148(3):128-33. doi: 10.1016/j.trsl.2006.04.005.
PubMed 16938650Houldsworth A, Metzner M, Rossol S, Shaw S, Kaminski E, Demaine AG, Cramp ME. Polymorphisms in the IL-12B gene and outcome of HCV infection. J Interferon Cytokine Res. 2005 May;25(5):271-6. doi: 10.1089/jir.2005.25.271.
PubMed 15871664Naito M, Matsui A, Inao M, Nagoshi S, Nagano M, Ito N, Egashira T, Hashimoto M, Mishiro S, Mochida S, Fujiwara K. SNPs in the promoter region of the osteopontin gene as a marker predicting the efficacy of interferon-based therapies in patients with chronic hepatitis C. J Gastroenterol. 2005 Apr;40(4):381-8. doi: 10.1007/s00535-005-1558-3.
PubMed 15868370Suzuki F, Arase Y, Suzuki Y, Tsubota A, Akuta N, Hosaka T, Someya T, Kobayashi M, Saitoh S, Ikeda K, Kobayashi M, Matsuda M, Takagi K, Satoh J, Kumada H. Single nucleotide polymorphism of the MxA gene promoter influences the response to interferon monotherapy in patients with hepatitis C viral infection. J Viral Hepat. 2004 May;11(3):271-6. doi: 10.1111/j.1365-2893.2004.00509.x.
PubMed 15117331
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analysis of Gene Expression of PBMC in the Hepatitis C Virus Genotype 1b-infected Patients During Peg-interferon-α Plus Ribavirin Combination Therapy
- ClinicalTrials.gov ID
- NCT00680173
- Acronym / sponsor ID
- PBMC / KMUH-IRB- 950419
- Conditions
- Chronic Hepatitis C
- Keywords
- Chronic Hepatitis C, Single nucleotide polymorphisms, Sustained virological response, Peginterferon, Ribavirin
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Study start
- Aug 2006
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 May 2008 (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.
Our previous collaborative studies has developed a molecular diagnosis tool, which is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs), for assessing the efficacy of interferon combined therapy for chronic hepatitis C (CHC) patients prior to treatment.
Aims of this project:
- To analyze and validate the gene expression profiling dependent of treatment response to peg-interferon-α plus ribavirin combination therapy in CHC genotype-1 patients.
- To select the candidate genes and establish a monitoring model assessing the efficacy of interferon treatment.
Detailed description
A combination of pegylated-interferon (PEG-IFN) with ribavirin has been the choice for treating chronic hepatitis C (CHC) patients. In addition to the high cost, the treatment takes 6 to 12 months and often brings significant adverse reactions to some patients. It would therefore be beneficial to include a pre-treatment evaluation and post-treatment monitoring system to maximize the efficacy of CHC therapy. We have established a molecular diagnosis tool for assessing the efficacy of interferon combined therapy for CHC patients prior to treatment. This diagnostic tool is characterized with a prediction model consisting single nucleotide polymorphisms (SNPs) strongly associated with interferon efficacy in treating CHC patients. The prediction model has been validated by hepatitis C samples in Taiwan, and it achieved 80 % accuracy, higher than the current efficacy rates. Supplemented with the viral genotype information would further increase the prediction accuracy to 85%.
In this project, we aim to analyze patients' gene expression profiling during the treatment. The current study will focus on 30 PEG-IFN and ribavirin treated patients with HCV genotype 1 infection. After the responding status of those patients has been confirmed, we will compare gene expression profiling among the different responses before and during treatment. By using this information, we can properly select the candidate genes, and establish a monitoring model with these biomarkers. This monitoring model can thus be applied to assess the efficacy of PEG-IFN plus ribavirin combination treatment.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Active comparator | Drug: pegylated interferon alpha 2a and plus ribavirin15 patients with HCV genotype 1 infection receiving peginterferon plus ribavirin achieve a sustained virological response |
| B | Active comparator | Drug: pegylated interferon alpha 2a and plus ribavirin15 patients with HCV genotype 1 infection receiving peginterferon plus ribavirin did not achieve a sustained virological response |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male and female patients >18 years of age
- Patients have never been treated with traditional interferon plus ribavirin or peginterferon plus ribavirin
- Serologic evidence of chronic hepatitis C infection by an anti-HCV antibody test
- Detectable serum HCV-RNA
- Liver biopsy findings consistent with the diagnosis of chronic hepatitis C infection with or without compensated cirrhosis (Exception: hemophiliacs in whom biopsy is medically contra-indicated do not require biopsy.)
Key exclusion criteria (22 listed)
- Women with ongoing pregnancy or breast feeding
- Present therapy with any systemic anti-neoplastic or immunomodulatory treatment (including supraphysiologic doses of steroids and radiation) within 6 months prior to the first dose of study drug
- Any investigational drug 6 weeks prior to the first dose of study drug
- Co-infection with active hepatitis A, hepatitis B and/or human immunodeficiency virus (HIV)
- History or other evidence of a medical condition associated with chronic liver disease other than HCV (e.g., hemochromatosis, autoimmune hepatitis, metabolic liver disease, alcoholic liver disease, toxin exposures)
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 |
|---|---|---|
| pegylated interferon alpha 2a and plus ribavirinAlso: PEGASYS®pegylated interferon alpha 2a 180 mcg/week and Ribavirin 1000-1200 mg/day for 24 weeks, follow up for 24 weeks | Drug | A, B |
Primary outcome
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period.
Time frame: 1.5 year
3 secondary outcomes
Rapid virologic response (RVR), HCV RNA seronegative by PCR at week 4.
Time frame: 1.5 year
Early virological response (EVR), by PCR-negative or at least 2 logs decline from baseline of serum HCV RNA at 12 weeks of treatment.
Time frame: 1.5 year
Safety - adverse event rate and profile
Time frame: 1.5 year
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 14 Mar 2016.
- Background: PubMed 16938650Dai CY, Chuang WL, Hsieh MY, Lee LP, Hou NJ, Chen SC, Lin ZY, Hsieh MY, Wang LY, Tsai JF, Chang WY, Yu ML. Polymorphism of interferon-gamma gene at position +874 and clinical characteristics of chronic hepatitis C. Transl Res. 2006 Sep;148(3):128-33. doi: 10.1016/j.trsl.2006.04.005.
- Background: PubMed 15871664Houldsworth A, Metzner M, Rossol S, Shaw S, Kaminski E, Demaine AG, Cramp ME. Polymorphisms in the IL-12B gene and outcome of HCV infection. J Interferon Cytokine Res. 2005 May;25(5):271-6. doi: 10.1089/jir.2005.25.271.
- Background: PubMed 15868370Naito M, Matsui A, Inao M, Nagoshi S, Nagano M, Ito N, Egashira T, Hashimoto M, Mishiro S, Mochida S, Fujiwara K. SNPs in the promoter region of the osteopontin gene as a marker predicting the efficacy of interferon-based therapies in patients with chronic hepatitis C. J Gastroenterol. 2005 Apr;40(4):381-8. doi: 10.1007/s00535-005-1558-3.
- Background: PubMed 15117331Suzuki F, Arase Y, Suzuki Y, Tsubota A, Akuta N, Hosaka T, Someya T, Kobayashi M, Saitoh S, Ikeda K, Kobayashi M, Matsuda M, Takagi K, Satoh J, Kumada H. Single nucleotide polymorphism of the MxA gene promoter influences the response to interferon monotherapy in patients with hepatitis C viral infection. J Viral Hepat. 2004 May;11(3):271-6. doi: 10.1111/j.1365-2893.2004.00509.x.
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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.
Wan-Long Chuang, MD, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing pegylated interferon alpha 2a and plus ribavirin in people with Chronic Hepatitis C, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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 8 inclusion and 22 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 14 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 1 site in Taiwan. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Efficacy - Sustained virological response (SVR), HCV RNA seronegative by PCR throughout 24-week off-treatment period. (time frame: 1.5 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00680173, which also lists 4 linked publications.
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 14 Mar 2016.