Recent Updates
Recently added Catalysts

Fibrinogen+ thrombin

Phase 3

Surgical Resection of Superficial Renal Tumour | Unknown | Oncology |Takeda Pharmaceutical Company Limited|Last Updated: Aug 3, 2012

Success Probability

Subscribe to view

Market & Valuation

Subscribe to view

Trial Design

RandomizedUNCONTROLLEDDMC
Total Trials1
Total Enrollment170

FDA Designations

No designations recorded

Clinical trial landscape

Fibrinogen+ thrombin · 1 trial · 1 indication

Phase 3 1
NCT00241163TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)Surgical Resection of Superficial Renal Tumour
COMPLETED170 Analytics
PHASE3COMPLETED
TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)
Surgical Resection of Superficial Renal Tumour
NCT00241163170
Unlock trial analytics

Study Endpoints

Primary Endpoints

Primary efficacy endpoint is overall time to intraoperative haemostasis from start of test treatment until haemostasis is obtained following 1 or 2 rounds of randomised treatment,and other haemostatic treatment, if necessary.

Secondary Endpoints

Secondary efficacy endpoints are: 1) proportion of patients with haemostasis 10 minutes after start of test treatment; 2) haematoma formation on day 2 after surgery (sonography).
Adverse events will be recorded from screening until follow-up.
Unlock Study Endpoints

Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Interventions

NameTypeDescription
Fibrinogen (human) + thrombin (human) (TachoSil)PROCEDURE -
Unlock Study Design Details

Eligibility Criteria

Age Range18 Years to 40 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: Patients of or above 18 years of age scheduled for resection of superficial tumour on the kidney and scheduled for open surgery. After the tumour resection the wound should be suitable for the treatments in the study, and the integrity of the urinary tract should be maintained. ...

Countries:Denmark
Unlock Eligibility Criteria

Frequently asked questions about Fibrinogen+ thrombin

What is Fibrinogen+ thrombin used for?

Fibrinogen+ thrombin is used for surgical resection of superficial renal tumour. It is being studied as a treatment to support surgical procedures in this oncology indication. The drug is currently in Phase 3 clinical development.

Who makes Fibrinogen+ thrombin?

Fibrinogen+ thrombin is developed by Takeda Pharmaceutical Company Limited, which trades under the ticker TAK. The company is conducting clinical trials to evaluate the drug's use in surgical resection of superficial renal tumour.

What phase is Fibrinogen+ thrombin in?

Fibrinogen+ thrombin is in Phase 3 clinical development. It is an investigational drug being studied for surgical resection of superficial renal tumour. The Phase 3 trial has been completed, but the drug is not yet approved.

What clinical trials is Fibrinogen+ thrombin in?

Fibrinogen+ thrombin has one completed Phase 3 trial, NCT00241163, titled 'TachoComb S Versus Standard Surgical Treatment in Surgical Resection of Renal Tumour (TC-015-IN)'. The trial enrolled 170 participants in Denmark and included adults aged 18 years and older.

Is Fibrinogen+ thrombin the same as TachoComb S?

Yes, Fibrinogen+ thrombin is the same as TachoComb S. The Phase 3 clinical trial NCT00241163 compares TachoComb S, which is Fibrinogen+ thrombin, against standard surgical treatment in surgical resection of superficial renal tumour.