Clinical Trial Details
— Status: Completed
Administrative data
NCT number |
NCT01502072 |
Other study ID # |
2011-0813 |
Secondary ID |
NCI-2012-00021 |
Status |
Completed |
Phase |
Phase 2
|
First received |
|
Last updated |
|
Start date |
December 28, 2011 |
Est. completion date |
February 1, 2020 |
Study information
Verified date |
January 2021 |
Source |
M.D. Anderson Cancer Center |
Contact |
n/a |
Is FDA regulated |
No |
Health authority |
|
Study type |
Interventional
|
Clinical Trial Summary
The goal of this clinical research study is to learn if ribavirin can help to control RSV in
patients with immune systems that have been weakened by a stem cell transplant. Researchers
also want to compare the effectiveness of the drug when it is given by mouth to when it is
inhaled. The safety of the drug in both methods of delivery will be studied.
Ribavirin is designed to prevent the RSV virus from making more copies of itself in the body.
Description:
Study Groups:
If you are found to be eligible to take part in this study and the study doctor thinks that
the disease requires treatment at this time, you will be randomly assigned (as in the flip of
a coin) to 1 of 2 study groups. You will have an equal chance of being assigned to either
group:
- If you are in Group 1, you will receive the inhaled form of ribavirin. You will inhale
ribavirin 3 times a day for 3 hours each time in a tent in a hospital room. You will
receive the drug for up to 10 days.
- If you are in Group 2, you will take capsules of ribavirin 3 times a day for up to 10
days.
If the study doctor does not think that the disease requires treatment at this time, you will
be assigned to Group 3. If you are in Group 3, you will not receive treatment with ribavirin,
but you will have the same tests and procedures at the study visits described below.
Study Visits:
At all study visits, you will be asked about how you are feeling, about any side effects or
symptoms you may be having, and about any other drugs you may be taking.
On Day 3 (+/- 1 day):
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
On Days 7 and 14 (+/- 1 day):
- Blood (about 2 teaspoons) will be drawn for routine tests.
- You will have a physical exam, including measurement of your vital signs
- Your nasal passages will be checked for RSV.
Length of Study:
If you are in Groups 1 or 2, you will receive the study drug for up to 10 days. You will no
longer be able to take the study drug if the disease gets worse, if intolerable side effects
occur, or if you are unable to follow study directions. If your doctor thinks you need
treatment longer than 10 days, you will receive that as part of your routine care. This may
mean changing to receiving the drug in inhaled form if you began the study receiving it by
mouth.
All participants will have end-of-study and follow-up visits, as described below.
End-of-Study Visit:
If you are in Groups 1 or 2, the end-of-study visit will be about 14 days after your last
dose of the study drug. If you are in Group 3, the end-of-study visit will take place at
about Day 21. The following tests and procedures will be performed:
- You will have a physical exam, including measurement of your vital signs.
- Blood (about 4 teaspoons) will be drawn for routine tests and to check for RSV
antibodies.
- Your nasal passages will be checked for RSV.
- You will be asked about how you are feeling, about any side effects or symptoms you may
be having, and about any drugs you may be taking.
Follow-Up Visit:
About 6 to 10 weeks after your last dose of study drug, you will have a pulmonary function
test to check your lung function.
This is an investigational study. Ribavirin is FDA approved and commercially available for
the treatment of hepatitis C when given by mouth, and for severe RSV in children when
inhaled. Giving the drug to adults with weak immune systems after a stem cell transplant is
investigational.
Up to 96 patients will take part in this study. All will be enrolled at MD Anderson.