DBV Technologies
Expanded Access Protocol of Viaskin® Peanut (DBV712) in Peanut-allergic Children
Conditions: Peanut Allergy
This is an open label expanded access program for male and female patients 2 years orolder, to provide continued desensitization treatment with DBV712 250 mcg.
Matrix Biomed, Inc.
Treatment of Metastatic Cancer in Terminally Diagnosed Patients
Conditions: Metastatic Cancer
The objective is to provide terminally diagnosed patients with a last line of treatmentwhile improving overall quality of life. Tempol can be added to any chemotherapy regimento potentially reduce side effects and overcome chemoresistance.
Neuraptive Therapeutics Inc.
NTX-001 to Repair Peripheral Nerve Transection(s)
Conditions: Peripheral Nerve Transections, Acute or Planned in Upper Extremity and Facial Nerves
The proposed use of NTX-001 for transections of upper extremity and facial peripheralnerves, acutely or planned.
Ellodi Pharmaceuticals, LP
Expanded Access Protocol for Patients With Eosinophilic Esophagitis
Conditions: Eosinophilic Esophagitis
This expanded access program is an open-label, single-arm design where consentingpatients may participate up until APT-1011 is commercially available in the relevantregions or the protocol is terminated by the Sponsor.
Celcuity Inc
Expanded Access Protocol for Subjects Previously Treated With Gedatolisib in B2151009
Conditions: Breast Neoplasm Malignant Female
Continued access to treatment for subjects who continue benefit from therapy withgedatolisib in combination with palbociclib, and fulvestrant or letrozole.
Bristol-Myers Squibb
Expanded Access for Apixaban
Conditions:
This is an expanded access designed to provide access to apixaban for eligibleparticipants.
Clene Nanomedicine
Two Intermediate Expanded Access Protocols (EAP) CNMAu8.EAP01 and CNMAu8.EAP02 for ALS
Conditions: Amyotrophic Lateral Sclerosis
The primary objective of the intermediate expanded access protocol is to provide accessto the investigational product, CNM-Au8, to up to 300 people living with ALS (pALS).No formal clinical hypotheses are being evaluated with concurrent controls.Secondary objectives include assessment of the safety of CNM-Au8 treatment in pALS.Safety will be assessed through the frequency of serious adverse events (SAEs),treatment-emergent adverse events (TEAEs) assessed as 'severe', discontinuations due toTEAEs, and laboratory abnormalities assessed as clinically significant during routineclinical monitoring (as applicable).
Novo Nordisk A/S
Compassionate Use of Concizumab if You Have Haemophilia
Conditions: Congenital Haemophilia
The compassionate use programme will give participants concizumab for free, even thoughit is not yet approved by health authorities. This is because participants need thismedicine to treat their haemophilia properly. The programme will check that participantsare safe and that the medicine works for them. The programme may last for years.Participants will take one injection under their skin every day. Participants will have4-5 visits with the study doctor for the first half year. After that they will have 1visit every half year. At all clinic visits participants will have blood samples taken.Participants will fill in a diary between the visits.A patient is considered to have completed the programme when any of the followingcriteria occurred first: 1) when the patient is included in a clinical trial withconcizumab or 2) up to 6 months after concizumab is commercially available in thepatient's country and approved for the patient (The time span of 6 months should provideample time for the patient to obtain concizumab commercially) or 3) the sponsor decidesto discontinue concizumab clinical development for the patient's population.