CompletedNot Applicable

Thrombocytopenia Induced by Chemotherapy

India60 participantsStarted 2017-07-18

Plain-language summary

Single blind, randomized, multicentric placebo controlled study to evaluate the efficacy of Study product in patient with Chemotherapy induced thrombocytopenia. The Study is divided into \[screening visit (visit 1) \> baseline and treatment allocation visit (visit 2) \>blood collection (visit 3); treatment compliance visit (visit 4) \> blood collection (visit 5) \>blood collection (visit 6)\>end of study visit (visit 7)\].

Who can participate

Age range18 Years – 55 Years

SexALL

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Inclusion criteria

✓. Male or female aged between 18-55 years.
✓. Subjects must sign with date an informed consent prior to any evaluation and participation in the trial.
✓. Patients who were confirmed solid tumour and received at least one cycle of chemotherapy prior to screening visit.
✓. Patients with a platelet counts between \> 20000 and \< 150,000/ml at the time of screening.

Exclusion criteria

✕. Planning to receive any type of surgery.
✕. Pregnant or lactating women.
✕. Patients with platelet count less than 20000/ml.
✕. Patients with thrombocytopenia presenting with active bleeding.
✕. Patients who have received blood or blood product transfusion during the current illness or during past one week.
✕. Patients with thrombocytopenia purpura (ITP) leukemia, hemophilia or bleeding diathesis.
✕. Participation in another trial with another investigational product

What they're measuring

Increase in the platelet counts from baseline levels to the end of therapy.

Timeframe: Day 15

Trial details

NCT IDNCT03567798

SponsorSocrates School Of Health

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2017-11-20

View on ClinicalTrials.gov More Thrombocytopenia trials