Autoimmune HepatitisPhase 3NCT01170351
Cyclosporine-A Versus Prednisolone for Induction of Remission in Auto-immune Hepatitis
A Phase 3 study testing Cyclosporine-A in people with Autoimmune Hepatitis, run by Tehran University of Medical Sciences at 1 site in Iran.
Trial summary
Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. Read more about this study
- Who is it for?
- Ages 16 to 65 years
- Conditions the study is for
- Autoimmune Hepatitis
- What is being tested?
- Cyclosporine-A
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 55 participants
- Where
- 1 siteIran
- Study dates
- Dec 2005to Dec 2018
- 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 16 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
- Willing and able to participate in the study
Who cannot join
- Non-consenting patients
- decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
- Presence of serious concomitant cardiovascular, pulmonary or renal condition
- Presence of active malignant disorder
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.
- Conditions
- Autoimmune Hepatitis
- Being tested
- Cyclosporine-A
- Keywords
- autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability
- Medical subject headings
- Hepatitis, Autoimmune
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cyclosporine-ADrug
Cyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data.
| Study group | Role | What they receive |
|---|---|---|
| Group-A | Active comparator | Treatment-naive AIH patients consenting to participate Receives: Drug: Cyclosporine-A |
| Group-B | Experimental | Treatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol. Receives: Drug: Cyclosporine-A |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission
AST/ALT less than 2x UNL No clinical symptom
Measured: 12 months
Treatment failure
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
Measured: 3 months
Secondary outcomes (2)
Frequency of adverse events
Any adverse event (related or unrelated to the study drug) occuring during the induction phase.
Measured: 12 months
Serious adverse event
Any adverse event requiring hospitalization or leading to disability or death
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2010 (estimated)
- Study startDec 2005
- Primary completionDec 2013
- Study completionDec 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune HepatitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tehran University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Siavosh Nasseri-Moghadam, Tehran University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01170351
- Sponsor's protocol ID
- DDRC-301174
- Status last verified
- Jul 2019
- First submitted
- 24 Jul 2010
- Last updated
- 19 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Efficacy and Tolerability of Cyclosporine-A vs. Prednisolone for Induction of Remission in Auto-immune Hepatitis
- ClinicalTrials.gov ID
- NCT01170351
- Acronym / sponsor ID
- DDRC-301174
- Conditions
- Autoimmune Hepatitis
- Keywords
- autoimmune hepatitis, corticosteroids, cysclosporine-A, treatment, treatment-naive, induction of remossion, efficacy, tolerability
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Tehran University of Medical SciencesUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 27 Jul 2010 (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.
Untreated Autoimmune hepatitis (AIH) is a progressive disease. Mainstay of treatment are corticosteroids (CS). In addition to being ineffective a substantial minority of cases, corticosteroid side-effects hamper effective therapy in another subgroup. Alternative options for induction of remission are limited. There are reports of successful salvage therapy with Cyclosporine-A (CsA) in steroid refractory cases. In addition, open-labeled studies have shown efficacy of Cyclosporine-A in treatment-naive AIH patients. There are no studies comparing CsA and CS in a head to head trial. The investigators aim to assess the efficacy and tolerability of CsA directly to the CS for induction of remission in treatment-naive AIH patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group-A | Active comparator | Drug: Cyclosporine-ATreatment-naive AIH patients consenting to participate |
| Group-B | Experimental | Drug: Cyclosporine-ATreatment-naive AIH patients consenting to participate. This group will receive Cyclosporine-A according to a set protocol. |
Who may qualify
- Ages
- 16 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 16-65 years old individuals with probable of definite AIH according to the revised AIH criteria.
- Willing and able to participate in the study
Key exclusion criteria (4 listed)
- Non-consenting patients
- decompensated cirrhosis, i.e. clinical ascites, hepatic encephalopathy, history of variceal bleeding
- Presence of serious concomitant cardiovascular, pulmonary or renal condition
- Presence of active malignant disorder
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 |
|---|---|---|
| Cyclosporine-ACyclosprorine-A will be administered to patients in group-B according to a set protocol and the patients will be followed at regular intervals with appropriate checking of clinical and para-clinical data. | Drug | Group-A, Group-B |
Primary outcome
Remission
Time frame: 12 months
AST/ALT less than 2x UNL No clinical symptom
Treatment failure
Time frame: 3 months
Failure to achieve AST/ALT less than 2x UNL despite adjusting dose according to protocol
2 secondary outcomes
Frequency of adverse events
Time frame: 12 months
Serious adverse event
Time frame: 12 months
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 19 Jul 2019.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Cyclosporine-A in people with Autoimmune Hepatitis, run by Tehran University of Medical Sciences at 1 site 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 4 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 19 Jul 2019. 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 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 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?
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?
Remission (time frame: 12 months). 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 19 Jul 2019.