Giant Lymph Node HyperplasiaPhase 4NCT00361933
Valganciclovir to Treat HHV-8 Associated Multicentric Castleman's Disease
A Phase 4 study testing Valganciclovir in people with Giant Lymph Node Hyperplasia, run by University of Washington.
Trial summary
The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Giant Lymph Node Hyperplasia
- What is being tested?
- Valganciclovir
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Dec 2008to May 2009
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years
- Negative pregnancy test (for female participants)
- Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually
- Evidence of infection with HHV-8
- A willingness to travel and reside temporarily in Seattle for completion of the study protocol.
- For HIV-infected participants, a stable antiretroviral regimen for the past 6 months
Who cannot join
- Concurrent Kaposi sarcoma or non-hodgkin's lymphoma
- A history or evidence of CMV disease
- Hypersensitivity to ganciclovir or valganciclovir
- Use of high-dose acyclovir (>800 mg bid), valacyclovir (>1000 mg qd) or famciclovir (>1000 mg qd), ganciclovir, foscarnet, or cidofovir
- Neutropenia (ANC <1500)
- Renal insufficiency with serum creatinine > 1.5 mg/ml or CrCl < 60
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- AST or ALT > 5 times upper limit of normal
- Concurrent administration of medications which are often associated with severe neutropenia or thrombocytopenia (i.e., chemotherapy, etc)
- Concurrent administration of probenecid or didanosine.
- Inability to read and understand English
About this study
Official title: Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study.
Read the detailed description
All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone.
Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant.
If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered.
The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed.
- Conditions
- Giant Lymph Node Hyperplasia
- Being tested
- Valganciclovir
- Medical subject headings
- Castleman Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ValganciclovirDrug
Also called Valcyte
valganciclovir open label, two 450mg tablets orally, twice a day
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Drug: Valganciclovir |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to improvement
Measured: 14 days
One-log reduction in HHV-8 peripheral blood viral load
Measured: 14 days
Secondary outcomes (3)
Safety and tolerability of valganciclovir
Measured: 14 days
Proportion of patients resolving symptoms by 4 days
Measured: 14 days
HHV-8 detection in the plasma or oropharynx
Measured: 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2006 (estimated)
- Study startDec 2008
- Primary completionMay 2009
- Study completionMay 2009 (estimated)
Why it stopped: Research never begun.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Giant Lymph Node HyperplasiaStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Hoffmann-La Roche
- Responsible party
- Principal investigator, Corey Casper, University of Washington
- Investigators
- Corey Casper, MD, MPH, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00361933
- Sponsor's protocol ID
- 30618
- Other IDs
- VAL096
- Status last verified
- Apr 2017
- First submitted
- 8 Aug 2006
- Last updated
- 18 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical and Virologic Response to HHV-8 Associated Multicentric Castleman's Disease to Valganciclovir
- ClinicalTrials.gov ID
- NCT00361933
- Acronym / sponsor ID
- 30618
- Conditions
- Giant Lymph Node Hyperplasia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Research never begun.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Hoffmann-La Roche
- Study start
- Dec 2008
- Primary completion
- May 2009 (actual)
- Study completion
- May 2009 (estimated)
- First posted
- 9 Aug 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to learn whether people who are experiencing an MCD (multicentric Castleman's Disease) flare will improve after taking valganciclovir. MCD is a type of inflammatory disease associated with Human Herpesvirus 8 (HHV-8). Valganciclovir is FDA approved for treating a different type of Human Herpesvirus, but not approved for the treatment of HHV-8. It is therefore considered experimental in this study.
Detailed description
All participants will undergo an initial screening appointment. At this visit, participants will be tested for Human Herpesvirus 8 (HHV-8), the virus that is associated with MCD, and we will review participants' medical history and medical records to determine whether he/she has MCD. If participants do not live within the Seattle area, this visit may occur over the phone.
Those who qualify for the study will be followed for up to 2 years. During that 2 year period, participants will be asked to collect oral swabs once a week and have blood drawn monthly. If subjects do not live within the Seattle-area, they will be asked to ship these samples to UW for testing. We will provide subjects with instructions for these shipments. This will be done at no cost to the participant.
If during the 2 year period the participant experiences a MCD flare, he/she will be admitted to the University of Washington Medical Center's Clinic Research Center for 14-days. If the participant does not live within the Seattle-area, all travel expenses will be covered.
The study will enroll a total of 8 patients who will receive open-label valganciclovir for 14-days. Everyday during the hospitalization, participants will have blood drawn (to check your HHV-8 levels), 1 oral swab will be collected and a general physical exam will be performed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Valganciclovir |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 years
- Negative pregnancy test (for female participants)
- Diagnosis of MCD for over one year, with a history of at least one MCD recurrence annually
- Evidence of infection with HHV-8
- A willingness to travel and reside temporarily in Seattle for completion of the study protocol.
Key exclusion criteria (10 listed)
- Concurrent Kaposi sarcoma or non-hodgkin's lymphoma
- A history or evidence of CMV disease
- Hypersensitivity to ganciclovir or valganciclovir
- Use of high-dose acyclovir (>800 mg bid), valacyclovir (>1000 mg qd) or famciclovir (>1000 mg qd), ganciclovir, foscarnet, or cidofovir
- Neutropenia (ANC <1500)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ValganciclovirAlso: Valcytevalganciclovir open label, two 450mg tablets orally, twice a day | Drug | 1 |
Primary outcome
Time to improvement
Time frame: 14 days
One-log reduction in HHV-8 peripheral blood viral load
Time frame: 14 days
3 secondary outcomes
Safety and tolerability of valganciclovir
Time frame: 14 days
Proportion of patients resolving symptoms by 4 days
Time frame: 14 days
HHV-8 detection in the plasma or oropharynx
Time frame: 14 days
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey Casper, MD, MPH principal investigator
University of Washington
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Valganciclovir in people with Giant Lymph Node Hyperplasia, run by University of Washington.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to improvement (time frame: 14 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2017.