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Study of the role of hydroxychloroquine in immunological and coagulation control in patients diagnosed with Primary antiphospholipid syndrome

Study of the role of hydroxychloroquine in immunomodulation and control of hypercoagulability in patients diagnosed with Primary antiphospholipid syndrome

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
REBEC
Registry ID
RBR-35mp4q
Enrollment
Unknown
Registered
2020-01-31
Start date
2014-11-11
Completion date
Unknown
Last updated
2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Embolism and thrombosis of unspecified vein

Interventions

Twenty-seven patients diagnosed with primary antiphospholipid syndrome received, in association with oral anticoagulation, 400 mg of hydroxychloroquine per day for 6 months. At the beginning and at th
Drug
D03.633.100.810.050.180.350

Sponsors

Hemocentro- Universidade Estadual de Campinas
Lead Sponsor
Hemocentro- Universidade Estadual de Campinas
Collaborator

Eligibility

Age
17 Years to 65 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of primary antiphospholipid syndrome with thrombosis; age between 17 and 65 years old

Exclusion criteria

Exclusion criteria: Diagnosis of active neoplasia; presence of other associated autoimmune diseases; gestational period; antiphospholipid syndrome with isolated obstetric complications

Design outcomes

Primary

MeasureTime frame
Expected Outcome 1: Comparison of the mean difference after 6 months of hydroxychloroquine use and non-use, by analysis by flow cytometry, of lymphocyte subpopulations - B, NK, TCD4, TCD8, TREG -in patients with primary APS;Outcome found 1: CD8 + and CD4 + T cells showed decreased counts during treatment and remained unchanged during the untreated period. The TREG lymphocyte count increased during treatment with HCQ (mean variation of 0.2U, 95% CI 0 to 0.4) and decreased in the period without treatment with the medication (mean variation of -0.6U, 95% CI -0.9 to -0.1);Expected Outcome 2: Comparison of the mean difference after 6 months of hydroxychloroquine use and non-use, by analysis by flow cytometry, of the expression of tissue factor at monocytes and platelets and in the D-Dimer levels in patients with primary APS;Expected outcome 2: It was not observed significant changes at monocyte-related tissue factor , at platelet-related tissue factor levels and D-dimer levels in this study;Expected Outcome 3: Comparison of the mean difference after 6 months of hydroxychloroquine use and non-use in lipid and glycemic profiles in patients with primary APS ;Found Outcome 3: Serum glycemia and low density lipoprotein (LDL) levels decreased during HCQ use (7% and 12% respectively) and did not change significantly in the period without the use of HCQ—

Secondary

MeasureTime frame
There are no secondary outcome in this study—

Countries

Brazil

Contacts

Public ContactFernanda;Sabrina Orsi;Mangolin

Hemocentro- Universidade Estadual de Campinas;Hemocentro- Universidade Estadual de Campinas

ferorsi@unicamp.br;sabrina_saraiva@yahoo.com.br+551935218382;+551935218283

Outcome results

None listed

Source: REBEC (via WHO ICTRP)