CLINICAL TRIALS PROFILE FOR FRAGMIN

All Clinical Trials for Fragmin

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	National Cancer Institute (NCI)	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	Upjohn	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00006083 ↗	Dalteparin to Prevent Complications in Cancer Patients Receiving Chemotherapy Through a Catheter	Completed	Jonsson Comprehensive Cancer Center	Phase 3	2000-04-01	RATIONALE: The use of dalteparin may be able to prevent complications caused by the use of a catheter to supply chemotherapy to cancer patients. It is not yet known if dalteparin is effective in reducing these complications. PURPOSE: Randomized phase III trial to determine the effectiveness of dalteparin in preventing catheter-related complications in cancer patients who are receiving chemotherapy through a catheter.
NCT00041782 ↗	Outpatient Treatment Of Deep Venous Thrombosis Using Subcutaneous Dalteparin (Fragmin) In Low Risk Cancer Patients	Terminated	Brookdale University Hospital Medical Center	Phase 2	2000-10-01	Study Plan: Adult cancer patients who have a low risk profile and present with DVT will receive dalteparin 200 IU/kg subcutaneously daily (based on actual body weight with a maximum dose of 18,000 IU). Eligible patients who have signed the informed consent will be instructed on injection technique, will give themselves their first subcutaneous injection under supervision of the physician or the nurse and will be observed for a minimum of 1-2 hours prior to discharge. Patients may be admitted to an observation unit for up to 24 hours prior to discharge if medically necessary. Those patients without complications during the observation period will be given discharge instructions and an outpatient schedule to see one of the physician investigators daily for their subcutaneous injection of dalteparin, routine lab work and initiation of oral anticoagulation therapy. Patients that are proficient in administering their own injection with dalteparin will be evaluated every other day by the physician investigator. On days of home injection, the study nurse will call the patient to check on the patient's status and to remind the patient of his/her daily injection. Patients will undergo a physical examination every other day by the physician investigator directed towards the clinically affected areas until a therapeutic response (INR 2-3) on oral warfarin has been achieved or the patient's clinical condition warrants modification of therapy with or without hospitalization. Patients will remain on study for a minimum of 5 days with at least 1 day of therapeutic oral anticoagulation. The quality of life of the patients enrolled will be assessed by using the Modified Medical Outcome Study Short Form-20. An adapted version of the Rotterdam Symptom Checklist will be used to specifically assess patients with thrombosis. Patients will complete these two instruments at study entry, day 3, day 5 and at the end of study if different from day 5.

Clinical Trial Conditions for Fragmin

Condition Name

Condition Name for Fragmin
Intervention	Trials
Venous Thromboembolism	10
Pulmonary Embolism	4
Deep Venous Thrombosis	3
Thromboembolism	3

Condition MeSH

Condition MeSH for Fragmin
Intervention	Trials
Thromboembolism	19
Venous Thromboembolism	13
Thrombosis	12
Venous Thrombosis	8

Clinical Trial Locations for Fragmin

Trials by Country

Trials by Country for Fragmin
Location	Trials
United States	78
Canada	53
Russian Federation	8
United Kingdom	5
Norway	5

Trials by US State

Trials by US State for Fragmin
Location	Trials
Texas	7
California	5
Missouri	4
New York	4
North Carolina	4

Clinical Trial Progress for Fragmin

Clinical Trial Phase

Clinical Trial Phase for Fragmin
Clinical Trial Phase	Trials
Phase 4	9
Phase 3	12
Phase 2/Phase 3	2

Clinical Trial Status

Clinical Trial Status for Fragmin
Clinical Trial Phase	Trials
Completed	23
Recruiting	4
Terminated	4

Clinical Trial Sponsors for Fragmin

Sponsor Name

Sponsor Name for Fragmin
Sponsor	Trials
Pfizer	12
Canadian Institutes of Health Research (CIHR)	5
Eisai Inc.	4

Sponsor Type

Sponsor Type for Fragmin
Sponsor	Trials
Other	53
Industry	20
NIH	5

FRAGMIN: Clinical Trials, Market Analysis, and Projections

Introduction

FRAGMIN, also known as dalteparin sodium, is a low molecular weight heparin (LMWH) widely used for the prevention and treatment of various thromboembolic conditions. Here, we will delve into the recent clinical trials, market analysis, and future projections for this drug.

Clinical Trials and Indications

Prophylaxis and Treatment Indications

FRAGMIN is indicated for several clinical uses, including the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, prophylaxis of deep vein thrombosis (DVT) in patients undergoing abdominal surgery, hip replacement surgery, or those with severely restricted mobility during acute illness, and the extended treatment of symptomatic venous thromboembolism (VTE) in patients with cancer[1][3].

Pediatric Patients

A significant milestone was the FDA approval of FRAGMIN for reducing the recurrence of symptomatic VTE in pediatric patients aged 1 month and older. This approval was based on two prospective, single-arm, multi-center clinical trials involving 52 pediatric patients. The trials demonstrated that 92% of patients achieved therapeutic anti-Xa levels, and no patients experienced progression of the qualifying VTE, with only one patient experiencing recurrence[4].

Dosage and Administration

The dosing regimen for FRAGMIN varies depending on the indication. For example, in patients with unstable angina or non-Q-wave myocardial infarction, the recommended dose is 120 units/kg subcutaneously every 12 hours, along with concurrent aspirin therapy. For DVT prophylaxis in abdominal surgery, the dose is typically 2500 IU subcutaneously once daily or 5000 IU subcutaneously 2-4 hours before surgery[1][3].

Adverse Reactions and Safety

Clinical trials have highlighted several adverse reactions associated with FRAGMIN. These include thrombocytopenia, which was reported in 10.9% of patients in one study, and injection site bruising, contusion, and epistaxis in pediatric patients. There is also a Boxed Warning regarding the risk of epidural or spinal hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture[1][4].

Market Analysis

Global Market Size and Growth

The global FRAGMIN market has shown significant growth over the years. As of 2023, the market size was substantial, with a compound annual growth rate (CAGR) projected to continue through 2031. The market is segmented by type, application, and region, providing insights into the most lucrative segments and future market opportunities[2][5].

Regional Analysis

The market analysis includes detailed insights into regional consumption and revenue. The report covers major regions such as North America, Europe, Asia-Pacific, and others, highlighting the consumption volume, value, and growth rate in each region. For instance, the European market is analyzed by country, including Germany, the UK, France, Italy, Spain, Poland, and Russia[5].

Competitive Landscape

The FRAGMIN market is dominated by key players such as Pfizer, Inc. The report provides profiles of these companies, including product analysis, sales, price, revenue, and gross margin. This competitive analysis helps in understanding the market positioning and potential growth strategies for both new entrants and existing competitors[5].

Market Projections

Forecasted Growth

The global FRAGMIN market is forecasted to continue growing from 2025 to 2031. The report provides quantitative and qualitative analyses to understand the driving factors for the fastest-growing segments. The forecast includes market size analysis by consumption volume and value, as well as growth rate projections by region and type[2][5].

Segment Analysis

The market is segmented by type and application, with detailed forecasts for each segment. For example, the report analyzes the global FRAGMIN consumption and revenue by type, such as the different dosing regimens and formulations, and by application, including the various clinical indications[5].

Economic and Industry Trends

The report also includes an analysis of the latest industry trends, driving factors, and restraining factors. It provides insights into mergers, acquisitions, and investments, as well as market dynamics that could impact the growth of the FRAGMIN market. This includes an analysis of the impact of COVID-19 on the market and consumer behavior[2][5].

Key Takeaways

• Clinical Indications: FRAGMIN is used for prophylaxis of ischemic complications, DVT prophylaxis, and extended treatment of VTE in patients with cancer, as well as in pediatric patients.
• Clinical Trials: Recent trials have expanded its use to pediatric patients, showing efficacy and safety in this population.
• Market Growth: The global FRAGMIN market is projected to grow significantly from 2025 to 2031, driven by increasing demand and expanding clinical indications.
• Regional Analysis: The market is analyzed by region, with detailed insights into consumption and revenue in various countries.
• Competitive Landscape: Pfizer, Inc. is a major player, and the report provides a competitive analysis to help understand market positioning and growth strategies.

FAQs

What are the primary indications for FRAGMIN?

FRAGMIN is indicated for the prophylaxis of ischemic complications in unstable angina and non-Q-wave myocardial infarction, prophylaxis of DVT in abdominal surgery, hip replacement surgery, or medical patients with severely restricted mobility, and extended treatment of symptomatic VTE in patients with cancer[1][3].

What is the significance of the FDA approval for pediatric patients?

The FDA approval of FRAGMIN for pediatric patients aged 1 month and older marks the first FDA-approved therapy to treat VTE in this population, providing a critical treatment option for a previously underserved group[4].

How does the dosing regimen vary for different indications?

The dosing regimen for FRAGMIN varies by indication; for example, 120 units/kg subcutaneously every 12 hours for unstable angina, and 2500 IU subcutaneously once daily for DVT prophylaxis in abdominal surgery[1][3].

What are the common adverse reactions associated with FRAGMIN?

Common adverse reactions include thrombocytopenia, injection site bruising, contusion, and epistaxis. There is also a risk of epidural or spinal hematomas in patients receiving neuraxial anesthesia or undergoing spinal puncture[1][4].

What is the projected growth rate of the global FRAGMIN market?

The global FRAGMIN market is projected to grow at a significant CAGR from 2025 to 2031, driven by increasing demand and expanding clinical indications[2][5].

Who are the major players in the FRAGMIN market?

Pfizer, Inc. is a major player in the FRAGMIN market, and the report provides detailed profiles of key companies, including product analysis, sales, price, revenue, and gross margin[5].

Sources

1. FRAGMIN® (dalteparin sodium) injection, USP, for subcutaneous use. FDA.
2. Fragmin Market Report 2024 (Global Edition). Cognitivemarketresearch.com.
3. HIGHLIGHTS OF PRESCRIBING INFORMATION. Hemonc.org.
4. FDA approves dalteparin sodium for VTE in pediatric patients. FDA.gov.
5. Global Fragmin Consumption Market Research Report 2013-2025. Maiaresearch.com.