Efficacy and Safety of Therapeutic Plasma Exchange vs Standard Medical Therapy in Severe Autoimmune Hepatitis.

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorInstitute of Liver and Biliary Sciences, India

About this trial

Autoimmune hepatitis (AIH) is a chronic inflammatory liver disease that can lead to cirrhosis and liver failure. AIH can present in all ages, races, and ethnicities, but it mostly affects women. As a heterogeneous disease, AIH presents variably in different patients, making diagnosis and treatment a challenge.It is associated with varied clinical presentations and natural history and somewhat unpredictable treatment responses. Steroids and immunosupressants are main stay of treatment.In acute severe presentations corticosteroid response rates are more variable.According to treatment guidelines if patients fail to respond to corticosteroids, Liver transplant is the only option. But Liver transplant is not feasible in all situations such as limited donor availability.Plasma exchange is associated with a reduction in levels of pro-inflammatory cytokines,DAMPs, and bacterial endotoxins and increase in the levels of anti-inflammatory cytokines.Plasma exchange has reportedly been used for acute presentations of AIH but there are few trials which prove its independent benefit and role in influencing transplant free survival.The study aims at proving the efficacy of Plasma exchange as a bridge between steroid therapy and Liver transplant.It includes the patients with acute severe autoimmune hepatitis .One group of patients are taken up for plasma exchange sessions and compared with the other group started on high dose of steroids and they will be observed for 28 days and are assessed for transplant free survival and efficacy of plasma exchange in reducing transaminitis and Bilirubin levels.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age 18-60 years

Acute severe autoimmune hepatitis with MELD >24

No liver transplant option < 28 days.

-ACLF + Non ACLF

Disqualifiers

Patients with Active sepsis

Patients with Active bleeding

Patients allergic to FFP and blood products

Patients with unstable hemodynamics ( eg:BP<90/60 mmhg,HR >100bpm)

Trial design

Design model

Parallel

Treatments tested in this trial

  • Plasma Exchange

    Biological/Vaccine

    3 to 5 sessions alternate day

  • Steroid

    Drug

    Steroid

  • Diet

    Dietary supplement

    Diet

Treatment groups

50 Participants
are divided into 2 treatment groups
Group A: Plasma ExchangeExperimental treatment 2 interventions
Group B: Standard Medical TreatmentActive comparator 2 interventions

Trial outcomes

Primary outcomes

1

Number of patients with change in AST,ALT,Bilirubin

Time frame
28 days

Secondary outcomes

1

Liver transplant free survival at 28 days.

Time frame
28 days
2

Development of adverse event due to TPE

Time frame
28 days
3

Number of patients with development of clinical infection during study period

Clinical infections includes pneumonia, SBP,UTI,soft tissue infections,blood stream infections.

Time frame
28 days
4

Mortality during hospital stay

Time frame
28 days

Other outcomes

Sponsors and contacts

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