Clinical trial on cancer patients

Phase 3

• Conditions: Health Condition 1: C801- Malignant (primary) neoplasm, unspecified

• Registration Number: CTRI/2023/06/053738
• Lead Sponsor: Med Manor Organics Private Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 August 2023

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

1.Subjects of both genders aged between 18 to 75 years.

2.Subjects undergoing chemotherapy for non hematological malignancies.

3.Willing and able to sign written informed consent

Exclusion Criteria

1.Present or past history of acute pro-myelocytic leukemia (APML), immune thrombocytopenic purpura (ITP), thrombotic thrombocytopenic purpura (TTP), or hemolytic-uremic syndrome (HUS).

2.Recent history of major surgery (within 2 weeks of study entry).

3.Currently taking, or participating in a study involving, platelet substitutes, platelet growth factors, or pharmacologic agents intended to enhance or decrease platelet hemostatic function.

4.Received high-dose steroids or IVIG in the 3 weeks prior to the start of the study.

5.Current HIV infection or hepatitis B virus or hepatitis C virus infections.

6.Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP.

7.Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia).

8.Female subjects who are nursing or pregnant, who may be pregnant, or who contemplate pregnancy during the study period.

9.Subjects with known diagnosis of autoimmune diseases, established in the medical history and / or laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.

10.Subjects who are deemed unsuitable for the study by the investigator.

11.Subjects with palpable splenomegaly =16 cm below subcostal margin.

12.Female subjects who are pregnant or breastfeeding. Women of childbearing potential are required to have a urine pregnancy test or serum ß-HCG performed within 3 days prior to first study drug dose. A female subject of childbearing potential is a sexually mature woman who has not undergone a hysterectomy or bilateral oophorectomy; or has not been naturally postmenopausal for at least 12 consecutive months (i.e., has had menses at any time in the preceding 12 consecutive months. Women of child-bearing potential and men must agree to use contraception prior to study entry and for the duration of study participation.

13.Subjects who had previously enrolled in this study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified