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NCT01419561 · ClinicalTrials.gov registry record · Phase 2
Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)
A Phase 2 study of KSHV Inflammatory Cytokine Syndrome (KICS) and HHV-8, sponsored by National Cancer Institute (NCI).
- Recruiting
- Registry status
- Phase 2
- Development phase
- 140
- Enrollment target
- 1
- Study location
NCT01419561: Recruiting Phase 2 study of KSHV Inflammatory Cytokine Syndrome (KICS) and HHV-8, sponsored by National Cancer Institute (NCI).
NCT01419561 is a Phase 2 study of KSHV Inflammatory Cytokine Syndrome (KICS) and HHV-8 that is actively recruiting participants, run by National Cancer Institute (NCI). The registered enrollment target is 140 participants, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target. The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01419561, a Phase 2 study of KSHV Inflammatory Cytokine Syndrome (KICS) and HHV-8, is actively recruiting participants, sponsored by National Cancer Institute (NCI).
- RECRUITING
- Registry status
- Phase 2
- Development phase
- 140 participants
- Enrollment target
- 1
- Study location
Study Summary
Background: \- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People with KICS may also be at risk of getting other cancers associated with KSHV. These cancers include Kaposi sarcoma and lymphoma. Because KICS is a newly identified disease, more information is needed on how the disease works and what can be done to treat it. Objectives: \- To collect genetic and medical information from people with KSHV inflammatory cytokine syndrome. Eligibility: \- Individuals at least 18 years of age who have Kaposi sarcoma herpes virus and symptoms that resemble those caused by KICS. Design: * Participants will have regular study visits. The schedule will be determined by the study researchers. * Participants will provide a complete medical history and have a full physical exam. Blood and urine samples will be collected as well. * People with KICS that requires treatment may get new experimental treatments. These treatments may include antiviral drugs and chemotherapy drugs, depending on the nature of the disease. * Participants will have imaging studies, such as chest x-rays and computed tomography scans, to study the tumors. * Bone marrow and lymph node biopsies may be done to collect tissue samples for study. * Participants who have Kaposi sarcoma will have photographs taken of their lesions.
Primary Outcome
Description of the natural history of KICS, including the spectrum of clinical, laboratory and radiographic abnormalities seen in affected patients
Conditions Studied
Interventions
- DRUG Rituximab
- DRUG Zidovudine
- DRUG Liposomal Doxorubicin
- DRUG Valganiclovir
- OTHER Standard Therapies
Study Locations (1)
Maryland
- National Institutes of Health Clinical Center - Bethesda
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 140 participants |
| Start Date | 2011-09-08 |
| Est. Completion | 2028-12-31 |
| Phase | Phase 2 |
What NCT01419561 shows while recruiting
NCT01419561 is an interventional study that assigns participants to a tested intervention. The registered 140 participants enrollment target is mid-sized for trials with a published cap, roughly in line with the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target.
The record links to 3 conditions, with KSHV Inflammatory Cytokine Syndrome (KICS) appearing as the primary indexed condition, and to 5 interventions - of which Rituximab is the first listed.
NCT01419561 reports a single indexed study location in Maryland.
Frequently Asked Questions
What is clinical trial NCT01419561 about?
NCT01419561 is a clinical study titled "Natural History Study of the KSHV Inflammatory Cytokine Syndrome (KICS)". Background: \- KSHV inflammatory cytokine syndrome (KICS) is a newly recognized disease caused by Kaposi sarcoma-associated herpesvirus (KSHV). This virus can cause cancer. People with KICS can have severe symptoms. They include fever, weight loss, and fluid in the legs or abdomen. People with KICS...
What is the current status of trial NCT01419561?
This trial is currently recruiting. It is a Phase 2 study. The enrollment target is 140 participants. The study started on 2011-09-08. Estimated completion is 2028-12-31.
What conditions does trial NCT01419561 study?
This clinical trial studies the following conditions: KSHV Inflammatory Cytokine Syndrome (KICS), HHV-8, KSHV.
What interventions are being tested in trial NCT01419561?
The interventions under investigation include: Rituximab (DRUG), Zidovudine (DRUG), Liposomal Doxorubicin (DRUG), Valganiclovir (DRUG), Standard Therapies (OTHER).
Who is sponsoring clinical trial NCT01419561?
This trial is sponsored by National Cancer Institute (NCI), which has 3,257 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01419561 being conducted?
This trial has 1 study location across Maryland. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01419561's enrollment target sits among peer trials
140 512th of 2000 higher than 1,477 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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