Chronic Hepatitis cPhase 3NCT01655966
Vitamin D as an add-on Therapy With Pegylated Interferon and Ribavirin for Chronic Hepatitis c
A Phase 3 study testing vitamin D +pegylated interferon + ribavirin and pegylated interferon + ribavirin in people with Chronic Hepatitis c, run by Cairo University at 1 site in Egypt.
Trial summary
Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Chronic Hepatitis c
- What is being tested?
- vitamin D +pegylated interferon + ribavirin and pegylated interferon + ribavirin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- May 2012to Apr 2014
- Phase
- Phase 3
- 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
Who may be able to join
- Adult (male or female), 18 to 65 years of age, with chronic HCV infection
- Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
- Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
- Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
- Patients must be serum hepatitis B surface antigen (HBsAg) negative
- Negative Antinuclear Antibodies (ANA) or titer of < 1:160
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- Serum positive for anti-HCV antibodies and HCV-RNA
- Abdominal Ultrasound obtained within 3 months prior to entry in the study
- Electrocardiogram for men aged > 40 years and for women aged > 50 years
- Normal fundus examination
- Proper contraception measure throughout the course of treatment and six months later
- Female patients must not breast feed during therapy
Who cannot join
- Patients who previously received interferon
- HgbA1c > 7.5 or history of diabetes mellitus
- BMI > 34
- Women who are pregnant or breast-feeding
- Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
- Other causes of liver disease including autoimmune hepatitis
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- Transplant recipients receiving immune suppression therapy
- Screening tests positive for anti-HAV IgM Ab, HBsAg, anti-HBc IgM Ab or anti-HIV Ab
- Decompensated cirrhosis, history of variceal bleeding, ascites, hepatic encephalopathy, CTP score > 6 or MELD score > 8
- Absolute neutrophil count < 1500 cells/mm3; platelet count < 135,000 cells/mm3; hemoglobin < 12 g/dL for women and < 12.5 g/dL for men; or serum creatinine concentration ≥ 1.5 times ULN
- Hypothyroidism or hyperthyroidism not effectively treated with medication
- Alcohol consumption of > 40 grams per day or an alcohol use pattern that will interfere with the study
- History or other clinical evidence of significant or unstable cardiac disease
- History or other clinical evidence of chronic pulmonary disease associated with functional impairment
- Serious or severe bacterial infection(s)
- History of severe or uncontrolled psychiatric disease, including severe depression, history of suicidal ideation, suicidal attempts or psychosis requiring medication and/or hospitalization
- History of uncontrolled severe seizure disorder
- History of immunologically mediated disease requiring more than intermittent anti-inflammatory medications for management or that requires frequent or prolonged use of corticosteroids
- Patients with clinically significant retinal abnormalities
- Subjects receiving vitamin D for any other medical condition.
- Subjects with significant active rheumatologic or orthopaedic conditions.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.
Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.
- Conditions
- Chronic Hepatitis c
- Being tested
- vitamin D +pegylated interferon + ribavirin, pegylated interferon + ribavirin
- Keywords
- chronic hepatitis c, hcv, vitamin d
- Medical subject headings
- Hepatitis C, Chronic, Hepatitis C
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
vitamin D +pegylated interferon + ribavirinDrug
Vitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
pegylated interferon + ribavirinDrug
pegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks
| Study group | Role | What they receive |
|---|---|---|
| Standard of care | Active comparator | Group A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. Receives: Drug: pegylated interferon + ribavirin |
| Triple therapy | Experimental | Group B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. Receives: Drug: vitamin D +pegylated interferon + ribavirin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sustained virologic response
Undetectable HCV-RNA 24 weeks after end of treatment.
Measured: 72 weeks
Secondary outcomes (4)
rapid virologic response
undetectable HCV-RNA 4 weeks after commencement of treatment
Measured: 4 weeks
End-of-treatment response
undetectable HCV-RNA 48 weeks after commencement of treatment
Measured: 48 weeks
Adverse events
Adverse events that could be reasonably and temporally associated with administration of drugs
Measured: 72 weeks
early virologic response
Early virologic response: undetectable HCV-RNA 12 weeks after commencement of treatment.
Partial early virologic response: decrease of more than 2login HCV-RNA.
No early virologic response: increase, stationary or decreased less than 2log HCV-RNA.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2012 (estimated)
- Study startMay 2012
- Primary completionFeb 2014 (estimated)
- Study completionApr 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hepatitis cStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hany Shehab, Cairo University
- Investigators
- Tamer Elbaz, MD, Principal investigator, Cairo UniversityHany Shehab, MD, Study director, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01655966
- Sponsor's protocol ID
- RAIL002
- Status last verified
- Jan 2014
- First submitted
- 31 Jul 2012
- Last updated
- 29 Jan 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Vitamin D in Addition to Pegylated Interferon and Ribavirin Compared to Pegylated Interferon and Ribavirin Alone in the Treatment of Chronic Hepatitis C Genotype 4.
- ClinicalTrials.gov ID
- NCT01655966
- Acronym / sponsor ID
- RAIL002
- Conditions
- Chronic Hepatitis c
- Keywords
- chronic hepatitis c, hcv, vitamin d
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- May 2012
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Apr 2014 (estimated)
- First posted
- 2 Aug 2012 (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.
Chronic hepatitis C is endemic in Egypt with a high prevalence of the resistant genotype 4. Conventional standard of care treatment has modest response with only 50% sustained virologic response. Recent reports have suggested an augmented response with the addition of vitamin D. This is a prospective randomized trial to assess the effectiveness of adding vitamin D to standard of care for chronic hepatitis C genotype 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard of care | Active comparator | Drug: pegylated interferon + ribavirinGroup A: comprises 40 treatment-naive chronic hepatitis c patients who will receive the standard of care treatment: peginterferon Alfa 2a 160 ug once weekly and weight-based ribavirin 1000 or 1200 mg/day (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. |
| Triple therapy | Experimental | Drug: vitamin D +pegylated interferon + ribavirinGroup B: comprises 40 treatment-naive chronic HCV patients who will receive oral vitamin D 1mcg once daily plus peginterferon alfa-2a (160ug once weekly) and weight-based ribavirin 1000-1200 mg daily (based on body weight < 75 kg or ≥ 75 kg, respectively) in divided doses for 48 weeks. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Adult (male or female), 18 to 65 years of age, with chronic HCV infection
- Liver biopsy showing chronic hepatitis with significant fibrosis using Ishak scoring system
- Compensated liver disease; serum bilirubin < 1.5 mg/dl, INR no more than 1.5, serum albumin > 3.4, platelet count > 75,000 mm, and no evidence of hepatic decompensation (hepatic encephalopathy or ascites)
- Acceptable hematological and biochemical indices (hemoglobin 12.5g/dl for men and 12 g/dl for women; neutrophil count 1500/mm3 or more and serum creatinine < 1.5 mg/dl
- Patients must be serum hepatitis B surface antigen (HBsAg) negative
Key exclusion criteria (21 listed)
- Patients who previously received interferon
- HgbA1c > 7.5 or history of diabetes mellitus
- BMI > 34
- Women who are pregnant or breast-feeding
- Males whose female partners are either pregnant or of child-bearing potential or not using birth control and are sexually active
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 |
|---|---|---|
| vitamin D +pegylated interferon + ribavirinVitamin D: 1mcg once daily 48 weeks Pegylated interferon 160ug once weekly 48 weeks Ribavirin(> 75kg:1200 mg, <75kg:1000mg daily)48 weeks | Drug | Triple therapy |
| pegylated interferon + ribavirinpegylated interferon 160ug once weekly Ribavirin (> 75kg:1200 mg, <75kg:1000mg daily)48 weeks | Drug | Standard of care |
Primary outcome
Sustained virologic response
Time frame: 72 weeks
Undetectable HCV-RNA 24 weeks after end of treatment.
4 secondary outcomes
rapid virologic response
Time frame: 4 weeks
End-of-treatment response
Time frame: 48 weeks
Adverse events
Time frame: 72 weeks
early virologic response
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2014.
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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.
Tamer Elbaz, MD principal investigator
Cairo University
Hany Shehab, MD study director
Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing vitamin D +pegylated interferon + ribavirin and pegylated interferon + ribavirin in people with Chronic Hepatitis c, run by Cairo University at 1 site in Egypt.
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 12 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 29 Jan 2014. 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 Egypt. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
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?
Sustained virologic response (time frame: 72 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 29 Jan 2014.