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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

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.

Iran1 site

Digestive Disease Research Center, Shariati Hospital
Tehran, 14117

Other trials in Iran

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 groups in NCT01170351
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.

Dec 2005Dec 2018

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)

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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Autoimmune Hepatitis trials

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.

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.

Related trials for Autoimmune Hepatitis

RecruitingPhase 3
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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?

On the ClinicalTrials.gov record for NCT01170351.

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; AzTrials last refreshed its copy on 8 Nov 2026.