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Condition or disease:  

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Study type:  

All Studies   Interventional Studies (Clinical Trials)  Observational Studies     -- Patient Registries   Expanded Access Studies   x

 

Expanded Access Type:

• Individual Patients
• Intermediate-size Population
• Treatment IND/Protocol

Study Results:  

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Expanded Access:

• Available
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• Approved for marketing

Eligibility Criteria:

Age:  

x yearsOR

Age Group:  

Child (birth–17)
Adult (18–64)
Older Adult (65+)

Sex:  

All   Studies with Female Participants   Studies with Male Participants   x

Accepts Healthy Volunteers:  

Healthy volunteers may participate in the study

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Intervention/treatment:  

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Outcome Measure:  

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Sponsor / Collaborator:  

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Study IDs:  

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Country:  

United States Afghanistan Albania Algeria American Samoa Andorra Angola Antigua and Barbuda Argentina Armenia Aruba Australia Austria Azerbaijan Bahamas Bahrain Bangladesh Barbados Belarus Belgium Belize Benin Bermuda Bhutan Bolivia Bosnia and Herzegovina Botswana Brazil Brunei Darussalam Bulgaria Burkina Faso Burundi Cambodia Cameroon Canada Cape Verde Cayman Islands Central African Republic Chad Chile China Colombia Comoros Congo Congo, The Democratic Republic of the Costa Rica Croatia Cuba Cyprus Czech Republic Côte D'Ivoire Denmark Djibouti Dominica Dominican Republic Ecuador Egypt El Salvador Equatorial Guinea Eritrea Estonia Ethiopia Faroe Islands Fiji Finland Former Serbia and Montenegro Former Yugoslavia France French Guiana French Polynesia Gabon Gambia Georgia Germany Ghana Gibraltar Greece Greenland Grenada Guadeloupe Guam Guatemala Guinea Guinea-Bissau Guyana Haiti Holy See (Vatican City State) Honduras Hong Kong Hungary Iceland India Indonesia Iran, Islamic Republic of Iraq Ireland Israel Italy Jamaica Japan Jersey Jordan Kazakhstan Kenya Kiribati Korea, Democratic People's Republic of Korea, Republic of Kuwait Kyrgyzstan Lao People's Democratic Republic Latvia Lebanon Lesotho Liberia Libyan Arab Jamahiriya Liechtenstein Lithuania Luxembourg Macedonia, The Former Yugoslav Republic of Madagascar Malawi Malaysia Maldives Mali Malta Martinique Mauritania Mauritius Mayotte Mexico Moldova, Republic of Monaco Mongolia Montenegro Montserrat Morocco Mozambique Myanmar Namibia Nepal Netherlands Netherlands Antilles New Caledonia New Zealand Nicaragua Niger Nigeria Northern Mariana Islands Norway Oman Pakistan Panama Papua New Guinea Paraguay Peru Philippines Poland Portugal Puerto Rico Qatar Romania Russian Federation Rwanda Réunion Saint Kitts and Nevis Saint Lucia Saint Vincent and the Grenadines Samoa San Marino Saudi Arabia Senegal Serbia Seychelles Sierra Leone Singapore Slovakia Slovenia Solomon Islands Somalia South Africa South Sudan Spain Sri Lanka Sudan Suriname Swaziland Sweden Switzerland Syrian Arab Republic Taiwan Tajikistan Tanzania Thailand Togo Trinidad and Tobago Tunisia Turkey Uganda Ukraine United Arab Emirates United Kingdom United States Uruguay Uzbekistan Vanuatu Venezuela Vietnam Virgin Islands (U.S.) Yemen Zambia Zimbabwe x

 

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Location Terms:  

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Additional Criteria:

Phase:  

Early Phase 1	Phase 1	Phase 2
Phase 3	Phase 4	Not Applicable

Funder Type:  

NIH	Other U.S. Federal agency
Industry	All others (individuals, universities, organizations)

Study Documents:  

Study Protocols

Statistical Analysis Plans (SAPs)

Informed Consent Forms (ICFs)

FDAAA 801 Violations:  

FDAAA 801 Violations

Results Submitted:  

No Results Submitted Submitted, QC review not concluded --Submission with QC comments available x

Study Start:  

From x

To x

(MM/DD/YYYY)

Primary Completion:  

From x

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First Posted:  

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Results First Posted:  

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Last Update Posted:  

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