Chloroquine diphosphate 250mg/day associated to prednisone in variable doses

azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses

Chloroquine diphosphate 250mg/day associated to prednisone in variable doses
Chloroquine diphosphate: One pill of chloroquine diphosphate per day until the end of the study
prednisone: Prednisone 5-15 mg/day until the end of the study

Chloroquine Plus Prednisone

azathioprine in variable doses (50-150mg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study

Azathioprine Plus Prednisone

Total

Gender

The biochemical response is defined when there is normalization of hepatic enzymes, mainly AST and ALT.

azathioprine in variable doses (1-2mg/Kg/day) associated to prednisone in variable doses
prednisone: Prednisone 5-15 mg/day until the end of the study
azathioprine: azathioprine 1-2mg/Kg/day until the end of the study

Biochemical Response to Therapy

Histopathological response is achieved when there is minimal or no inflammation in hepatic tissue, as assessed by liver biopsy.

Histopathological Response to Therapy

Overall Study

Lydia Teófilo de Moraes Falcão

Autoimmune Hepatitis

One pill of chloroquine diphosphate per day until the end of the study

Chloroquine diphosphate

Prednisone 5-15 mg/day until the end of the study

prednisone

azathioprine 1-2mg/Kg/day until the end of the study

azathioprine

Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

Possible Role of Chloroquine in Conjunction to Prednisone to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

Association of Chloroquine and Prednisone as an Alternative Treatment for Autoimmune Hepatitis: a Randomized Trial

University of Sao Paulo General Hospital

Hepatitis, Autoimmune

Sugar pill (placebo) one pill per day for 1110 days Chloroquine diphosphate 250mg per day for 1110 days

Chloroquine diphosphate 250mg

Placebo

University of São Paulo School of Medicine

CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS

DOUBLE-BLIND RANDOMIZED CLINICAL TRIAL WITH CHLOROQUINE VERSUS PLACEBO FOR MAINTENANCE OF REMISSION OF AUTOIMMUNE HEPATITIS

To evaluate the rate of recurrence of autoimmune hepatitis with histological remission after withdrawal of corticosteroids and immunosuppressive drugs and after introduction of maintenance therapy with chloroquine or placebo. Recurrence is defined by the sustained increase or progressive liver enzymes above twice the upper normal reference value (as defined by the criteria of the International Autoimmune Hepatitis) in at least two different dosages taken with an interval of 15 to 30 days.

To assess the occurrence of side effects of chloroquine and to evaluate if the use of chloroquine has a cost benefit for maintenance of remission histological, we will investigate hematological, dermatological, opthalmological, neurological, musculoeskeletal and gastrintestinal symptoms. To evaluate the ocular toxicity, patients will undergo ophthalmic evaluation to detect retinal deposits of chloroquine every six months. Other side effects will be assessed in each medical consultation from the speech of patients and clinical examination.If necessary exams will be performed to confirm the diagnosis (eg electromyography in cases of suspected peripheral neuropathy by chloroquine)

To assess the occurrence of side effects of chloroquine and to evaluate if the use of chloroquine has a cost benefit for maintenance of remission histological. We will investigate hematological, dermatological, opthalmological, neurological, musculoeskeletal and gastrintestinal symptoms.
To evaluate ocular toxicity, patients will undergo ophthalmic evaluation to detect retinal deposits of chloroquine every six months. Other side effects will be assessed in each medical consultation from the talking of patients and clinical examinations. If necessary, other complementary exams will be performed to confirm the diagnosis (for instance, electromyography in cases of suspected peripheral neuropathy by chloroquine).

porphyria cutanea tarda/bolest hlavy

Possible Role of Chloroquine to Induce a Complete Remission in the Treatment of Autoimmune Hepatitis: a Randomized Trial

CHLOROQUINE FOR MAINTENANCE REMISSION OF AUTOIMMUNE HEPATITIS

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