Chronic Hepatitis CPhase 2HCVNCT02216045
Effect of Camel Milk on Chronic Hepatitis C
A Phase 2 study testing Peginterferon, Ribavirin, camel milk and Peginterferon, Ribavirin in people with Chronic Hepatitis C, run by Mashhad University of Medical Sciences at 2 sites in Iran.
Trial summary
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Chronic Hepatitis C
- What is being tested?
- Peginterferon, Ribavirin, camel milk and Peginterferon, Ribavirin
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 2 sitesIran
- Study dates
- Jun 2014to Feb 2015
- Phase
- Phase 2
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HCV (hepatitis C virus ) RNA positive
- Age age groups (18 to 70 years)
Who cannot join
- Ongoing pregnancy or breast feeding
- Hx of HCC(hepatocellular carcinoma )
- Hx of alcoholic liver disease
- Hx of bleeding from esophageal varices
- Hx of hemochromatosis
- Hx of autoimmune hepatitis
Show all 13Show fewer
- Hx of Suicidal attempt
- Hx of cerebrovascular dis
- Hx of severe retinopathy
- Hx of severe psoriasis
- Hx of scleroderma
- Hx of metabolic liver disease
- Hx of SLE(systemic lupus erythematosus )
Trial locations and contacts
2 sites in 1 country.
Iran2 sites
Faculty of Traditional Medicine
Mashhad, Razavi Khorasan Province
Mashhad University of Medical Sciences
Mashhad, Razavi Khorasan Province
About this study
Official title: Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
Read the detailed description
The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.
Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
- Conditions
- Chronic Hepatitis C
- Being tested
- Peginterferon, Ribavirin, camel milk, Peginterferon, Ribavirin
- Keywords
- Hepatitis C ,Chronic Hepatitis C ,camel milk
- 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.
Peginterferon, Ribavirin, camel milkDrug
Also called PEGASYS® COPEGUS®. Dromedary milk (camel milk )
Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks .
camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
Peginterferon, RibavirinDrug
Also called PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)
Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks.
Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Peginterferon ,Ribavirin | Active comparator | drug :Peginterferon, Ribavirin, Receives: Drug: Peginterferon, Ribavirin |
| Peginterferon, Ribavirin, camel milk | Experimental | drug :Peginterferon, Ribavirin, camel milk Receives: Drug: Peginterferon, Ribavirin, camel milk |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early Virologic Responses(EVR)
Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV.
Measured: After 4 weeks of Treatment
Early Virologic Responses(EVR)
Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk
Measured: 4 weeks after of treatment
Secondary outcomes (8)
Complete early virological response (cEVR)
defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV
Measured: 12 weeks after initiation of treatment
o Complete early virological response (cEVR)
defined by undetectable HCV RNA at 12 weeks post initiation of dual therapy by PEG IFN + RBV+camel milk
Measured: 12 weeks after initiation of treatment
o Sustained virological response (SVR)
defined by HCV RNA below the detection limit based on quantitative PCR 12 weeks after stopping treatment by PEG IFN +RBV
Measured: 12 weeks after initiation of treatment
o Sustained virological response (SVR)
defined by HCV RNA below the detection limit based on quantitative PCR(polymerase chain reaction ) 12 weeks after stopping treatment by PEG IFN +RBV+camel milk
Measured: 12 weeks after initiation of treatment
o Normalization of ALT( Alanine Aminotransferase)
Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV and 12 weeks after the end of treatment.
Measured: during the treatment and 12 weeks of treatment
o Normalization of ALT
Proportion of patients who have ALT below the upper limit of normal (ULN) during the treatment by PEG IFN +RBV+camel milk and 12 weeks after of treatment.
Measured: during the treatment and 12 weeks of treatment
o Adverse events(AE)
Number of participants experiencing adverse events
Measured: Up to 12 weeks
o Adverse events(AE)
Number of participants discontinuing study treatment because of adverse events
Measured: Up to 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2014 (estimated)
- Study startJun 2014
- Primary completionFeb 2015
- Study completionFeb 2015
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.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mashhad University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, mohammadreza noras, Mashhad University of Medical Sciences
- Investigators
- Seyyd Musa Al-Reza Hosseini, professor.As, Study chair, Ghaem Gastrointestinal ClinicMehdi Yousefi, MD.Phd, Study director, Faculty of Traditional Medicine ClinicMohammadreza Noras, Phd student, Principal investigator, Faculty of Traditional Medicine ClinicAli Taghipour, MD.Phd, Study director, MUMS Faculty of Health SciencesSaid Zibae, MD.Phd, Study director, Razi vaccine and serum Research Institue of Mashhd
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02216045
- Sponsor's protocol ID
- Mashhad UMS
- Acronym
- HCV
- Status last verified
- Jul 2016
- First submitted
- 26 Jul 2014
- Last updated
- 29 Jul 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- No: individual participant data (IPD) is confidential in researchers .
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Effects of Camel Milk Products on the Laboratory Markers in the Patients With Chronic Hepatitis C, Genotype 2 & 3
- ClinicalTrials.gov ID
- NCT02216045
- Acronym / sponsor ID
- HCV / Mashhad UMS
- Conditions
- Chronic Hepatitis C
- Keywords
- Hepatitis C ,Chronic Hepatitis C ,camel milk
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mashhad University of Medical SciencesUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Feb 2015 (actual)
- Study completion
- Feb 2015 (actual)
- First posted
- 13 Aug 2014 (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.
Camel milk as the new modality for treatment of chronic hepatitis C. The purpose of this study is to evaluate effectiveness and safety of camel milk in combination with Peginterferon Alfa-2a and Ribavirin in genotype 2,3 chronic hepatitis C virus .
Detailed description
The investigators enrolled 40 patients into the study. Group 1(Intervention ) : received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily and 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks.
Group 2 ( control ): received PEGASYS( Peginterferon ) One subcutaneous injection containing 0.5 ml solution with180 mcg per week plus COPEGUS( Ribavirin ) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for 12 weeks.
Follow up period is 1,2,3 months after treatment. The patients are visited every 4 weeks with biochemistry lab tests. The patients are checked with quantitative HCV RNA (Ribonucleic Acid) on the first months after initiation of the treatment to assess early virologic response and at the end of the study for complete response rate and on the third month after treatment completion for sustained response rate. The patients with undetectable HCV RNA are considered as responders.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Peginterferon ,Ribavirin | Active comparator | Drug: Peginterferon, Ribavirindrug :Peginterferon, Ribavirin, |
| Peginterferon, Ribavirin, camel milk | Experimental | Drug: Peginterferon, Ribavirin, camel milkdrug :Peginterferon, Ribavirin, camel milk |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- HCV (hepatitis C virus ) RNA positive
- Age age groups (18 to 70 years)
Key exclusion criteria (13 listed)
- Ongoing pregnancy or breast feeding
- Hx of HCC(hepatocellular carcinoma )
- Hx of alcoholic liver disease
- Hx of bleeding from esophageal varices
- Hx of hemochromatosis
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 |
|---|---|---|
| Peginterferon, Ribavirin, camel milkAlso: PEGASYS® COPEGUS®. Dromedary milk (camel milk )Peginterferon One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks . camel milk 250 ml of raw camel milk will be consumed in 10 minutes orally twice daily for 12 weeks. | Drug | Peginterferon, Ribavirin, camel milk |
| Peginterferon, RibavirinAlso: PEGASYS® (Peginterferon ) , COPEGUS® (Ribavirin)Peginterferon (PegIFNα-2a) One subcutaneous injection containing 0.5 ml solution with180 mcg PegIFNα-2a per week for 12 weeks. Ribavirin (RBV) tablets (body-weight adjusted dose: < 75 kg = 1000 mg and ≥ 75 kg = 1200 mg) taken orally (by mouth) once daily for for 12 weeks. | Drug | Peginterferon ,Ribavirin |
Primary outcome
Early Virologic Responses(EVR)
Time frame: After 4 weeks of Treatment
Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN ( interferon) + RBV.
Early Virologic Responses(EVR)
Time frame: 4 weeks after of treatment
Change From Baseline in Plasma Hepatitis C Virus (HCV) Ribonucleic Acid (RNA) Levels (log10 IU/mL) at Week 4 in Treatment by PEG IFN + RBV+camel milk
8 secondary outcomes
Complete early virological response (cEVR)
Time frame: 12 weeks after initiation of treatment
o Complete early virological response (cEVR)
Time frame: 12 weeks after initiation of treatment
o Sustained virological response (SVR)
Time frame: 12 weeks after initiation of treatment
o Sustained virological response (SVR)
Time frame: 12 weeks after initiation of treatment
o Normalization of ALT( Alanine Aminotransferase)
Time frame: during the treatment and 12 weeks of treatment
o Normalization of ALT
Time frame: during the treatment and 12 weeks of treatment
o Adverse events(AE)
Time frame: Up to 12 weeks
o Adverse events(AE)
Time frame: Up to 12 weeks
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 29 Jul 2016.
- Individual participant dataSharing planned: No. individual participant data (IPD) is confidential in researchers .
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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.
Seyyd Musa Al-Reza Hosseini, professor.As study chair
Ghaem Gastrointestinal Clinic
Mehdi Yousefi, MD.Phd study director
Faculty of Traditional Medicine Clinic
Mohammadreza Noras, Phd student principal investigator
Faculty of Traditional Medicine Clinic
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Peginterferon, Ribavirin, camel milk and Peginterferon, Ribavirin in people with Chronic Hepatitis C, run by Mashhad University of Medical Sciences at 2 sites in Iran.
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 2 inclusion and 13 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 29 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Iran. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Early Virologic Responses(EVR) (time frame: After 4 weeks of Treatment). 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 29 Jul 2016.